O.R./SURGEONS GOWN, ITEM NO. 4962— 510(k) K921155

Substantially Equivalent

The Sewing Source, Inc.

FDA 510(k) clearance K921155 for O.R./SURGEONS GOWN, ITEM NO. 4962, Substantially Equivalent on 1993-07-09. Applicant: The Sewing Source, Inc.. Device class: 2.

Clearance details

Applicant
The Sewing Source, 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
Spring Hope, NC, US
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