STERILE BARRIER SLEEVE AND COVER— 510(k) K930552

Name: FDA 510(k) clearance K930552
Creator: U.S. Food and Drug Administration
Published: 1994-07-05

Substantially Equivalent

Patient Safety Products, Inc.

FDA 510(k) clearance K930552 for STERILE BARRIER SLEEVE AND COVER, Substantially Equivalent on 1994-07-05. Applicant: Patient Safety Products, Inc.. Device class: 2.

Clearance details

Applicant: Patient Safety Products, Inc.
Product code: Code MMP
Device class: Class 2
Regulation: 21 CFR 878.4370
Advisory panel: General, Plastic Surgery
Date received: 1993-02-03
Decision date: 1994-07-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Brooklyn, NY, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.