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510(k) K921450

Device
NON-INVASIVE TUBING
Applicant
SPECIALTY MEDICAL SALES, INC.
510(k) number
K921450
Product code
FPK  
Decision
Substantially Equivalent (SESE)
Decision date
1993-02-05
Date received
1992-03-26
Regulation
880.5440
Classification name
Tubing, Fluid Delivery
Medical specialty
General Hospital
Review panel
General Hospital
Device class
2
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
MICHAEL MERCHANT
Address
10 Manor Pkwy. Salem NH US 03079 03079

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code FPK  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K131517MEDRAD TWIST & GO HIGH PRESSURE CONNECTOR TUBINGMedrad, Inc. / Bayer Medical Care, Inc.2013-08-02
K063114DISPOSABLE TRANSFER SETS WITH AND WITHOUT SWABBABLE VALVES AND/OR CHECK VALVESCoeur, Inc.2007-02-09
K063239LIFESHIELD LATEX-FREE GRAVITECH FLOW CONTROLLER I.V. SETS, MODELS 17528, 17527, 17525 & 17526Hospira, Inc.2006-12-11
K052431MEDTRONIC MINIMED LEAPFROG II INFUSION SET, MODELS MMT-801S1, MMT-801L1, MMT-801S2, MMT-801L2, MMT-803S1Medtronic Minimed2005-11-29
K041178EMPOWER TRANSFER SET, (CAT. NO. 7725)E-Z-Em, Inc.2004-07-16
K031808MEDRAD SWABBABLE VALVE TRANSFER SETMedrad, Inc.2003-07-11
K022431MEDRAD TRANSFER SETMedrad, Inc.2002-09-05
K965208POLYFIN EXTENSION SET, MODELS 126 AND 128Medtronic Minimed1997-02-26
K953864SILCLEAR TUBING (MODIFICATION)Degania Silicone , Ltd.1995-11-06
K950508SYSMEX SF-3000Sysmex Corp.1995-11-03
K952243EXTENSION SET/I.V. SETCoast Medical, Inc.1995-07-26
K95266360 MICRO VOLUME EXTENSION SET W/.22 MICRON FILTER, 21 EXTENSION SET W/1.2 MIVTON GILYRT, INJ. SITE, CLAMPDistronic Sterile Products, Inc.1995-07-14
K950861RECONSTITUTION ACCESSOREISOrganon, Inc.1995-05-26
K933524EXTENTION SETMediziv Medical Products 1987 , Ltd.1995-05-23
K950200IVIDScott/Ross Designs, Inc.1995-03-24

Legacy Summary#

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FDA Review#

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