SILICATH-AG SILICONE ELASTOMER FOLEY CATHETER

Collector, Urine, (and Accessories) For Indwelling Catheter

TRAVENOL LABORATORIES, S.A.

The following data is part of a premarket notification filed by Travenol Laboratories, S.a. with the FDA for Silicath-ag Silicone Elastomer Foley Catheter.

Pre-market Notification Details

Device IDK860362
510k NumberK860362
Device Name:SILICATH-AG SILICONE ELASTOMER FOLEY CATHETER
ClassificationCollector, Urine, (and Accessories) For Indwelling Catheter
Applicant TRAVENOL LABORATORIES, S.A. Deerfield,  IL  60015
ContactRobert L Wilkinson
CorrespondentRobert L Wilkinson
TRAVENOL LABORATORIES, S.A. Deerfield,  IL  60015
Product CodeKNX  
CFR Regulation Number876.5250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1986-01-30
Decision Date1986-04-29

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