BARNER SHOE COVERS & COVERBOOTS— 510(k) K760779

Substantially Equivalent

Surgikos, Inc.

FDA 510(k) clearance K760779 for BARNER SHOE COVERS & COVERBOOTS, Substantially Equivalent on 1976-11-02. Applicant: Surgikos, Inc.. Device class: 1.

Clearance details

Applicant
Surgikos, Inc.
Product code
Code FXP
Device class
Class 1
Regulation
21 CFR 878.4040
Advisory panel
General, Plastic Surgery
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Mchenry, IL, US
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