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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bandage, Liquid
510(k) Number K935783
Device Name MITRAFLEX CAVITY WOUND DRESSING
Applicant
POLYMEDICA INDUSTRIES, INC.
581 CONFERENCE PL.
GOLDEN,  CO  80401
Applicant Contact ANDREW M REED, PH.D.
Correspondent
POLYMEDICA INDUSTRIES, INC.
581 CONFERENCE PL.
GOLDEN,  CO  80401
Correspondent Contact ANDREW M REED, PH.D.
Regulation Number880.5090
Classification Product Code
KMF  
Date Received12/06/1993
Decision Date 02/04/1994
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
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