ENVIROTEX REUSABLE O.R. WRAPPER AND CUSTOM SURGICAL DRAPE— 510(k) K960045

Name: FDA 510(k) clearance K960045
Creator: U.S. Food and Drug Administration
Published: 1996-06-05

Substantially Equivalent

The Sewing Source, Inc.

FDA 510(k) clearance K960045 for ENVIROTEX REUSABLE O.R. WRAPPER AND CUSTOM SURGICAL DRAPE, Substantially Equivalent on 1996-06-05. Applicant: The Sewing Source, Inc.. Device class: 2.

Clearance details

Applicant: The Sewing Source, Inc.
Product code: Code KKX
Device class: Class 2
Regulation: 21 CFR 878.4370
Advisory panel: General, Plastic Surgery
Date received: 1996-01-02
Decision date: 1996-06-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Spring Hope, NC, US

Download summary PDF View on FDA.gov ↗

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