STERILE DISPOSABLE PN DRAPE SYSTEM— 510(k) K850912

Name: FDA 510(k) clearance K850912
Creator: U.S. Food and Drug Administration
Published: 1985-05-03

Substantially Equivalent

Brant-Wald Surgicals, Inc.

FDA 510(k) clearance K850912 for STERILE DISPOSABLE PN DRAPE SYSTEM, Substantially Equivalent on 1985-05-03. Applicant: Brant-Wald Surgicals, Inc.. Device class: 2.

Clearance details

Applicant: Brant-Wald Surgicals, Inc.
Product code: Code KKX
Device class: Class 2
Regulation: 21 CFR 878.4370
Advisory panel: General, Plastic Surgery
Date received: 1985-03-05
Decision date: 1985-05-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Oak Ridge, TN, US

Download summary PDF View on FDA.gov ↗

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