Michael Wojnovich

FDA Filings

This page includes the latest FDA filings for Michael Wojnovich. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)
Registration Number3001313714
FEI Number3002807293
NameMichael Wojnovich
Owner & OperatorINTERSURGICAL UAB
Contact AddressARNIONIU 60/28-1 --
PABRADE LT-NOTA LT-4710 LT
Official Correspondent
  • Ivan Seniut
  • 370-37-01766611-x
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address6757 Kinne St
East Syracuse, NY 13057 US
Establishment Type
  • Manufacture Medical Device for Another Party (Contract Manufacturer)
  • Manufacture Medical Device
  • Complaint File Establishment per 21 CFR 820.198

Registration Number3015168843
FEI Number3015168843
NameMichael Wojnovich
Owner & OperatorIntersurgical Medical Apparatus (Changzhou) Co., Ltd.
Contact AddressNo. 1011, Liaohe Road, Xinbei District
Changzhou City CN-32 Jiangsu 213125 CN
Official Correspondent
  • Ivan Seniut
  • 86-519-69817033-x
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address6757 Kinne Street
East Syracuse, NY 13057 US
Establishment TypeRepack or Relabel Medical Device

FDA Filings

Device
Company
DeviceDate
Michael Wojnovich [Intersurgical Medical Apparatus (Changzhou) Co., Ltd.]
Crush Resistant Tubing2019-01-31
Michael Wojnovich [INTERSURGICAL UAB]
C-PEEP fixed value valve, yellow, preset at 7.5cm H2O 22070002017-05-05
Michael Wojnovich [INTERSURGICAL UAB]
C-PEEP fixed value valve, yellow, preset at 7.5cm H2O 22050002017-05-05
Michael Wojnovich [INTERSURGICAL UAB]
C-PEEP fixed value valve, red, preset at 15cm H2O 22150002017-05-05
Michael Wojnovich [INTERSURGICAL UAB]
C-PEEP fixed value valve, green, preset at 10cm H2O 22100002017-05-05
Michael Wojnovich [INTERSURGICAL UAB]
C-PEEP fixed value valve, dark pink, preset at 12.5cm H2O 22120002017-05-05
Michael Wojnovich [INTERSURGICAL UAB]
C-PEEP fixed value valve, brown, preset at 20cm H2O 22200002017-05-05
Michael Wojnovich [INTERSURGICAL UAB]
C-PEEP fixed value valve preset, black, 2.5cm H2O 22020002017-05-05
Michael Wojnovich [INTERSURGICAL UAB]
Adjustable peep valve 2.5-20cmH2O 22m 22260002017-05-05
Michael Wojnovich [INTERSURGICAL UAB]
nFlow nasal mask 47050002017-04-20
Michael Wojnovich [INTERSURGICAL UAB]
nFlow nasal mask 47040002017-04-20
Michael Wojnovich [INTERSURGICAL UAB]
Mapleson D deluxe Bain coaxial breathing system - 21160002017-03-01
Michael Wojnovich [INTERSURGICAL UAB]
Mapleson D deluxe Bain coaxial breathing system - 21150002017-03-01
Michael Wojnovich [INTERSURGICAL UAB]
Mapleson D Bain coaxial breathing system - 21100002017-03-01
Michael Wojnovich [INTERSURGICAL UAB]
MAPLESON D DELUXE BAIN COAXIAL B/SYSTEM - 21150102017-03-01
Michael Wojnovich [INTERSURGICAL UAB]
Catheter Mount2015-10-20
Michael Wojnovich [INTERSURGICAL UAB]
Face Fit NIV Mask2015-09-18
Michael Wojnovich [INTERSURGICAL UAB]
Inter-Therm Mini Pediatric HMEF sterile and Inter-Therm Mini Pediatric angled HMEF sterile2015-02-16
Michael Wojnovich [INTERSURGICAL UAB]
OROCARE SUCTION LINE SPLITTER 30220002014-07-29
Michael Wojnovich [INTERSURGICAL UAB]
OROCARE SENSITIVE ORAL SUCTION WAND 30170002014-07-29
Michael Wojnovich [INTERSURGICAL UAB]
OROCARE ASPIRE SUCTION TOOTHBRUSH 30160002014-07-29
Michael Wojnovich [INTERSURGICAL UAB]
Exhalation Valves2014-06-05
Michael Wojnovich [INTERSURGICAL UAB]
1690030 Flo-Guard Breathing Filter2013-04-22
Michael Wojnovich [INTERSURGICAL UAB]
n-flow infant bonnets2012-07-26
Michael Wojnovich [INTERSURGICAL UAB]
28200002012-04-26
Michael Wojnovich [INTERSURGICAL UAB]
2810, 2820, 28302012-04-26
Michael Wojnovich [INTERSURGICAL UAB]
OROCARE MINI TOOTHBRUSH 30110002012-01-03
Michael Wojnovich [INTERSURGICAL UAB]
Quadralite Masks, Explorer Masks2011-09-19
Michael Wojnovich [INTERSURGICAL UAB]
Filta-Guard & Filta-Therm Breathing Filters2011-05-03
Michael Wojnovich [INTERSURGICAL UAB]
Hydro-Guard and Air-Guard Breathing Filters2011-05-03
Michael Wojnovich [INTERSURGICAL UAB]
Inter-Therm HMEF & Inter-Guard Filter2010-11-08
Michael Wojnovich [INTERSURGICAL UAB]
2310030, 2320030, 2330030, RM213632010-05-19
Michael Wojnovich [INTERSURGICAL UAB]
2026030, 2026031, RM21361, RM213622010-05-19
Michael Wojnovich [INTERSURGICAL UAB]
2310030, 2320030, 2330030, RM213632010-05-19
Michael Wojnovich [INTERSURGICAL UAB]
2026030, 2026031, RM21361, RM213622010-05-19
Michael Wojnovich [INTERSURGICAL UAB]
19222007-11-12
Michael Wojnovich [INTERSURGICAL UAB]
Clear-Therm Mini2007-11-12
Michael Wojnovich [INTERSURGICAL UAB]
Clear-Guard Midi2007-11-12
Michael Wojnovich [INTERSURGICAL UAB]
Filta-Therm HMEF2007-11-12
Michael Wojnovich [INTERSURGICAL UAB]
Cirrus and Micro-Cirrus2007-11-12
Michael Wojnovich [INTERSURGICAL UAB]
Clear-Therm Micro HMEF2007-11-12
Michael Wojnovich [INTERSURGICAL UAB]
1102030, 12926000, 1181030, 11926000, 120260002003-08-14
Michael Wojnovich [INTERSURGICAL UAB]
1161030, 1162030, 1163030, 1164030, 1165030, 1166030, 1167030, 1160030, 1160031, 11600322003-08-14
Michael Wojnovich [INTERSURGICAL UAB]
RM213232003-08-14
Michael Wojnovich [INTERSURGICAL UAB]
RM21301 thru RM213092003-08-14
Michael Wojnovich [INTERSURGICAL UAB]
B0062000 Breathing Circuit2003-08-14
Michael Wojnovich [INTERSURGICAL UAB]
2900, 2901, 2902, 29032003-08-14
Michael Wojnovich [INTERSURGICAL UAB]
Guedel Airways, Solus Laryngeal Masks, i-gel supraglottic airways2003-08-14
Michael Wojnovich [INTERSURGICAL UAB]
23160302003-08-14
Michael Wojnovich [INTERSURGICAL UAB]
RM21341 thru RM213432003-08-14
Michael Wojnovich [INTERSURGICAL UAB]
1987, 1988, 1989, 1900, 1901, 1902, 1903, 1997030,2003-08-14
Michael Wojnovich [INTERSURGICAL UAB]
1945, 1946, 1947, 1948, 1949, 1960, 1961, 1962, 1963, 1964, 1965, 1966, 1967, 1968, 1933, 1980, 1982, 1983, 1984, 1985,2003-08-14
Michael Wojnovich [INTERSURGICAL UAB]
1174030, 14760302003-08-14
Michael Wojnovich [INTERSURGICAL UAB]
RM21351, RM21353, RM213542003-08-14
Michael Wojnovich [INTERSURGICAL UAB]
193030, 1931030, 151060002003-08-14
Michael Wojnovich [INTERSURGICAL UAB]
1911030, 19120302003-08-14
Michael Wojnovich [INTERSURGICAL UAB]
Oxygen Mask2003-08-14
Michael Wojnovich [INTERSURGICAL UAB]
1188030, 1108030, 1116030, 1216030, 1190030, 1196030, 1198030,2003-08-14
Michael Wojnovich [INTERSURGICAL UAB]
1117030, 1118030, 1137030, 1138030, 1118030, 11996000, 10246000, 10286000, 10316000, 10356000, 10406000, 10606000,2003-08-14
Michael Wojnovich [INTERSURGICAL UAB]
Hydro-Therm, Hydro-Trach T2003-08-14

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