LIGHT HANDLE COVER

Drape, Surgical

CONCEPT, INC.

The following data is part of a premarket notification filed by Concept, Inc. with the FDA for Light Handle Cover.

Pre-market Notification Details

Device IDK832278
510k NumberK832278
Device Name:LIGHT HANDLE COVER
ClassificationDrape, Surgical
Applicant CONCEPT, INC. 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 Received1983-07-12
Decision Date1983-09-29

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