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510(k) K965146

Device
FLAT CLOSED WOUND DRAIN WITH TROCAR
Applicant
AXIOM MEDICAL, INC.
510(k) number
K965146
Product code
GBX  
Decision
Substantially Equivalent (SESE)
Decision date
1997-03-10
Date received
1996-12-23
Regulation
878.4200
Classification name
Catheter, Irrigation
Medical specialty
General & Plastic Surgery
Review panel
General & Plastic Surgery
Device class
1
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
RIDWAN HARDY
Address
555 W. Victoria St. Rancho Dominguez CA US 90220 90220

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code GBX  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K131659MOERAE VEIN PREPARATION KITMoerae Matrix, Inc.2014-03-03
K082725GRAFTGUARD PRESSURE CONTROLLING SYRINGEMaquet Cardiovascular, LLC2008-12-17
K052286DEUTSCH ANTI-BLOCKAGE WOUND DRAINThe Catheter Exchange, Inc.2005-10-21
K043515GRAFTSAVERVescare, Inc.2005-03-31
K013417MISONIX IRRIGATION SYSTEM MOEDL BC20PMisonix, Inc.2002-01-10
K000704DMC SAPHENOUS VEIN DISTENTION SYSTEM (SVDS)Dmc Medical, Ltd.2000-05-19
K974233LYSONIX IRRIGATION SYSTEMLysonix, Inc.1998-02-03
K973703JACKSON-PRATT HEMADUCT WOUND DRAIN, JACKSON-PRATT GOLD HEMADUCT WOUND DRAINAllegiance Healthcare Corp.1997-12-04
K972635ULTRACELL SUCTION SPONGEUltracell Medical Technologies, Inc.1997-10-01
K961295SAPPHIRE LINE FLAT DRAIN/KIT WITH SPI-ARGENT II W/OR W/OUT TROCARSil-Med Corp.1996-06-26
K961147CLOSED FLUID COLLECTION SYSTEMB.Braun Medical, Inc.1996-05-31
K960955JACKSON-PRATT GOLD WOUND DRAINS WITH DURAFLO II COATINGBaxter Healthcare Corp1996-05-22
K955339HYDROLOGY 5000Northgate Technologies, Inc.1996-03-13
K955474NEO-PNEUMOCATHIntra Special Catheters GmbH1996-02-13
K955505OPTI-DRAIN MULTI-USE DRAINAGE CATHETERNavarre Biomedical , Ltd.1996-02-07

Legacy Summary#

summary

FDA Review#

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