NON-STERILE & STERILE DISPOSABLE SURGICAL DRAPES— 510(k) K861288

Name: FDA 510(k) clearance K861288
Creator: U.S. Food and Drug Administration
Published: 1986-05-06

Substantially Equivalent

Procedure Pak, Inc.

FDA 510(k) clearance K861288 for NON-STERILE & STERILE DISPOSABLE SURGICAL DRAPES, Substantially Equivalent on 1986-05-06. Applicant: Procedure Pak, Inc.. Device class: 2.

Clearance details

Applicant: Procedure Pak, Inc.
Product code: Code KKX
Device class: Class 2
Regulation: 21 CFR 878.4370
Advisory panel: General, Plastic Surgery
Date received: 1986-04-07
Decision date: 1986-05-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Asheville, NC, US

Download summary PDF View on FDA.gov ↗

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