PHARMASEAL RUBBER URETHRAL CATHETER

Catheter, Urological

AMERICAN PHARMASEAL DIV. AHSC

The following data is part of a premarket notification filed by American Pharmaseal Div. Ahsc with the FDA for Pharmaseal Rubber Urethral Catheter.

Pre-market Notification Details

Device IDK874517
510k NumberK874517
Device Name:PHARMASEAL RUBBER URETHRAL CATHETER
ClassificationCatheter, Urological
Applicant AMERICAN PHARMASEAL DIV. AHSC 27200 NORTH TOURNEY RD. POST OFFICE BOX 5900 Valencia,  CA  91355
ContactRobert T Merrick
CorrespondentRobert T Merrick
AMERICAN PHARMASEAL DIV. AHSC 27200 NORTH TOURNEY RD. POST OFFICE BOX 5900 Valencia,  CA  91355
Product CodeKOD  
CFR Regulation Number876.5130 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-11-02
Decision Date1987-12-03

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