BARRIER* OVERHEAD TABLE DRAPE

Drape, Surgical

SURGIKOS, INC.

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

Pre-market Notification Details

Device IDK791439
510k NumberK791439
Device Name:BARRIER* OVERHEAD TABLE DRAPE
ClassificationDrape, Surgical
Applicant SURGIKOS, 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 Received1979-07-31
Decision Date1979-08-28

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