SHIELD DISP. PATIENTS PONCHO GOWNS— 510(k) K801570

Name: FDA 510(k) clearance K801570
Creator: U.S. Food and Drug Administration
Published: 1980-07-28

Substantially Equivalent

American Convertors Div., American Pharmaseal

FDA 510(k) clearance K801570 for SHIELD DISP. PATIENTS PONCHO GOWNS, Substantially Equivalent on 1980-07-28. Applicant: American Convertors Div., American Pharmaseal. Device class: 2.

Clearance details

Applicant: American Convertors Div., American Pharmaseal
Product code: Code FYB
Device class: Class 2
Regulation: 21 CFR 878.4040
Advisory panel: General, Plastic Surgery
Date received: 1980-07-08
Decision date: 1980-07-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, 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.