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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, Drug
510(k) Number K932676
Device Name SPYROFILM IQ WOUND DRESSING(WITH INERT FILLER)
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
FRO  
Date Received06/02/1993
Decision Date 12/10/1993
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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