AMER. PHARMASEAL SILICONIZED LATEX

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 Amer. Pharmaseal Siliconized Latex.

Pre-market Notification Details

Device IDK841544
510k NumberK841544
Device Name:AMER. PHARMASEAL SILICONIZED LATEX
ClassificationCatheter, Urological
Applicant AMERICAN PHARMASEAL DIV. AHSC 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeKOD  
CFR Regulation Number876.5130 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1984-04-16
Decision Date1984-07-09

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