SPYROFLEX WOUND CLOSURES— 510(k) K921775

Name: FDA 510(k) clearance K921775
Creator: U.S. Food and Drug Administration
Published: 1992-05-19

Substantially Equivalent

Polymint Industrial Co. , Ltd.

FDA 510(k) clearance K921775 for SPYROFLEX WOUND CLOSURES, Substantially Equivalent on 1992-05-19. Applicant: Polymint Industrial Co. , Ltd.. Device class: 1.

Clearance details

Applicant: Polymint Industrial Co. , Ltd.
Product code: Code FPX
Device class: Class 1
Regulation: 21 CFR 880.5240
Advisory panel: General Hospital
Date received: 1992-04-10
Decision date: 1992-05-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wheat Ridge, CO, US

Download summary PDF View on FDA.gov ↗

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