BARNER SHOE COVERS & COVERBOOTS

Cover, Shoe, Operating-room

SURGIKOS, INC.

The following data is part of a premarket notification filed by Surgikos, Inc. with the FDA for Barner Shoe Covers & Coverboots.

Pre-market Notification Details

Device IDK760779
510k NumberK760779
Device Name:BARNER SHOE COVERS & COVERBOOTS
ClassificationCover, Shoe, Operating-room
Applicant SURGIKOS, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeFXP  
CFR Regulation Number878.4040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1976-10-05
Decision Date1976-11-02

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.