MAI STERILE UTILITY DRAPE— 510(k) K853347

Name: FDA 510(k) clearance K853347
Creator: U.S. Food and Drug Administration
Published: 1985-09-05

Substantially Equivalent

Medical Assoc. Intl., Inc.

FDA 510(k) clearance K853347 for MAI STERILE UTILITY DRAPE, Substantially Equivalent on 1985-09-05. Applicant: Medical Assoc. Intl., Inc.. Device class: 2.

Clearance details

Applicant: Medical Assoc. Intl., Inc.
Product code: Code KKX
Device class: Class 2
Regulation: 21 CFR 878.4370
Advisory panel: General, Plastic Surgery
Date received: 1985-08-12
Decision date: 1985-09-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Topeka, KS, US

Download summary PDF View on FDA.gov ↗

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