SURGICAL DRAPE KIT

Drape, Surgical

NOBELPHARMA USA, INC.

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

Pre-market Notification Details

Device IDK933148
510k NumberK933148
Device Name:SURGICAL DRAPE KIT
ClassificationDrape, Surgical
Applicant NOBELPHARMA USA, INC. 5101 S. KEELER AVE. Chicago,  IL  60632
ContactAlan I Becker
CorrespondentAlan I Becker
NOBELPHARMA USA, INC. 5101 S. KEELER AVE. Chicago,  IL  60632
Product CodeKKX  
CFR Regulation Number878.4370 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-06-29
Decision Date1995-06-26

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