SURGIKOS INCISE DRAPE

Drape, Surgical

SURGIKOS, INC.

The following data is part of a premarket notification filed by Surgikos, Inc. with the FDA for Surgikos Incise Drape.

Pre-market Notification Details

Device IDK820542
510k NumberK820542
Device Name:SURGIKOS INCISE DRAPE
ClassificationDrape, Surgical
Applicant SURGIKOS, INC. 4221 Richmond Rd., N.W. Walker,  MI  49534
Product CodeKKX  
CFR Regulation Number878.4370 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1982-03-02
Decision Date1982-06-02

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