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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dressing, Wound And Burn, Occlusive
510(k) Number K953885
Device Name SPYROFLEX SKIN PROTECTOR
Applicant
Polymedica Industries, Inc.
581 Conference Pl.
Golden,,  CO  80401
Applicant Contact ANDREW M REED
Correspondent
Polymedica Industries, Inc.
581 Conference Pl.
Golden,,  CO  80401
Correspondent Contact ANDREW M REED
Classification Product Code
MGP  
Date Received08/17/1995
Decision Date 11/29/1995
Decision Substantially Equivalent (SESE)
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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