TACKMER INCISE DRAPE

Drape, Surgical

AMERICAN CONVERTORS DIV., AMERICAN PHARMASEAL

The following data is part of a premarket notification filed by American Convertors Div., American Pharmaseal with the FDA for Tackmer Incise Drape.

Pre-market Notification Details

Device IDK802050
510k NumberK802050
Device Name:TACKMER INCISE DRAPE
ClassificationDrape, Surgical
Applicant AMERICAN CONVERTORS DIV., AMERICAN PHARMASEAL 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeKKX  
CFR Regulation Number878.4370 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1980-08-25
Decision Date1980-09-16

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