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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Strip, Adhesive, Closure, Skin
510(k) Number K921775
Device Name SPYROFLEX WOUND CLOSURES
Applicant
Polymint Industrial Co. , Ltd.
4080 Youngfield St.
Wheat Ridge,  CO  80033
Applicant Contact ANDREW M REED
Correspondent
Polymint Industrial Co. , Ltd.
4080 Youngfield St.
Wheat Ridge,  CO  80033
Correspondent Contact ANDREW M REED
Regulation Number880.5240
Classification Product Code
FPX  
Date Received04/10/1992
Decision Date 05/19/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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