BARRIER FASHION BONNET

Hood, Surgical

SURGIKOS, INC.

The following data is part of a premarket notification filed by Surgikos, Inc. with the FDA for Barrier Fashion Bonnet.

Pre-market Notification Details

Device IDK760865
510k NumberK760865
Device Name:BARRIER FASHION BONNET
ClassificationHood, Surgical
Applicant SURGIKOS, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeFXY  
CFR Regulation Number878.4040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1976-10-18
Decision Date1976-11-03

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