SURGICAL UTILITY DRAPE

Declotting Tray, Kit (including Contents)

MEGAPLAST, INC.

The following data is part of a premarket notification filed by Megaplast, Inc. with the FDA for Surgical Utility Drape.

Pre-market Notification Details

Device IDK821313
510k NumberK821313
Device Name:SURGICAL UTILITY DRAPE
ClassificationDeclotting Tray, Kit (including Contents)
Applicant MEGAPLAST, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeFJZ  
CFR Regulation Number876.5820 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1982-05-04
Decision Date1982-06-21

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