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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tape And Bandage, Adhesive
510(k) Number K932457
Device Name SPYROGEL WOUND DRESSING
Applicant
Polymint Industrial Co. , Ltd.
581 Conference Pl.
Golden,,  CO  80401
Applicant Contact ANDREW M REED
Correspondent
Polymint Industrial Co. , Ltd.
581 Conference Pl.
Golden,,  CO  80401
Correspondent Contact ANDREW M REED
Regulation Number880.5240
Classification Product Code
KGX  
Date Received05/21/1993
Decision Date 02/09/1994
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
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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