COMPEL 1-PLY SURGICAL GOWNS; COMPEL ISOLATION GOWNS— 510(k) K041653

Substantially Equivalent

Standard Textile Co., Inc.

FDA 510(k) clearance K041653 for COMPEL 1-PLY SURGICAL GOWNS; COMPEL ISOLATION GOWNS, Substantially Equivalent on 2005-07-01. Applicant: Standard Textile Co., Inc.. Device class: 2.

Clearance details

Applicant
Standard Textile Co., Inc.
Product code
Code FYA
Device class
Class 2
Regulation
21 CFR 878.4040
Advisory panel
General, Plastic Surgery
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Cincinnati, OH, US
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