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510(k) K954197

Device
Disposable Flex Tube
Applicant
ENGSTROM MEDICAL
510(k) number
K954197
Product code
BZA
Decision
Substantially Equivalent (SESE)
Decision date
1995-10-26
Date received
1995-09-06
Regulation
868.5810
Classification name
Connector, Airway (Extension)
Medical specialty
Anesthesiology
Review panel
Anesthesiology
Device class
1
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
WULF TREPTE
Address
Box 20109 Karlsbodavagen 18 S-161 02 Bromma SE

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code BZA#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K083702TRACH-ASSISTMergenet Medical2009-03-05
K954383SURELOC CIRCUIT CONNECTORPolamedco, Inc.1995-12-22
K953786UNICOR, INC. CONNECTORS & AIRWAY EXTENSIONSUnicor, Inc.1995-09-19
K952824NEO-LINK, DISPOSABLE NEONATAL AIR WAY CONNECTORIntertex Medical, Inc.1995-07-20
K951345DISPOSABLE AIRWAY CONNECTORS FOR GAS SAMPLINGCatheter Research, Inc.1995-04-14
K944532PRIMA, INC. VENTILATOR HOSESPrima, Inc.1994-12-02
K944535PRIMA, INC. GAS SAMPLING LINES AND CONNECTORSPrima, Inc.1994-11-29
K944534PRIMA, INC. CONNECTORS AND AIRWAY EXTENSIONSPrima, Inc.1994-11-29
K942392AIRWAY CONNECTOR WITH FLEX TUBEMallinckrodt Medical1994-08-22
K941026THAYER MASK TO MOUTHPIECE ADAPTER/CONNECTORThayer Medical Corp.1994-08-18
K940793DOUBLE TRACH SWIVEL CONNECTORSeven Harvest Intl. Import & Export1994-07-01
K940544DOUBLE TRACH SEIVEL CONNECTORFvtnks1994-04-19
K935821DOUBLE TRACH SWIVEL CONNECTORNutec, Inc.1994-01-14
K931800MAG CONNECTORS AND AIRWAY EXTENSIONSMag, Inc.1993-05-19
K931345CONNECTORS AND AIRWAY EXTENSIONSPrecision Med Products, Ltd.1993-04-23