SHIELD PERFECT FIT; DURA-FIT, DISPOS.— 510(k) K800528

Name: FDA 510(k) clearance K800528
Creator: U.S. Food and Drug Administration
Published: 1980-04-16

Substantially Equivalent

American Convertors Div., American Pharmaseal

FDA 510(k) clearance K800528 for SHIELD PERFECT FIT; DURA-FIT, DISPOS., Substantially Equivalent on 1980-04-16. Applicant: American Convertors Div., American Pharmaseal. Device class: 1.

Clearance details

Applicant: American Convertors Div., American Pharmaseal
Product code: Code FXP
Device class: Class 1
Regulation: 21 CFR 878.4040
Advisory panel: General, Plastic Surgery
Date received: 1980-03-07
Decision date: 1980-04-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, 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.