SHOE COVER— 510(k) K972227

Substantially Equivalent

American Seal Co.

FDA 510(k) clearance K972227 for SHOE COVER, Substantially Equivalent on 1997-09-09. Applicant: American Seal Co.. Device class: 1.

Clearance details

Applicant: American Seal Co.
Product code: Code FYF
Device class: Class 1
Regulation: 21 CFR 878.4040
Advisory panel: General, Plastic Surgery
Date received: 1997-06-13
Decision date: 1997-09-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hayward, CA, US

Download summary PDF View on FDA.gov ↗

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K953878 — BOUFFANT CAP1996-01-05

More clearances from American Seal Co.

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K892553 — MAYTEX PATIENT EXAMINATION GLOVES1989-05-25

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