SURGICAL GOWN, REINFORCED

Gown, Surgical

SURGIKOS, INC.

The following data is part of a premarket notification filed by Surgikos, Inc. with the FDA for Surgical Gown, Reinforced.

Pre-market Notification Details

Device IDK772182
510k NumberK772182
Device Name:SURGICAL GOWN, REINFORCED
ClassificationGown, Surgical
Applicant SURGIKOS, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeFYA  
CFR Regulation Number878.4040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1977-11-25
Decision Date1977-12-08

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