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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, Occlusive
510(k) Number K873277
Device Name MITRAFLEX(TM) WOUND DRESSING
Applicant
Matrix Medica, Inc.
4050 Youngfield St.
Wheat Ridge,  CO  80033
Applicant Contact KERRY L GRAF
Correspondent
Matrix Medica, Inc.
4050 Youngfield St.
Wheat Ridge,  CO  80033
Correspondent Contact KERRY L GRAF
Regulation Number878.4020
Classification Product Code
NAD  
Date Received08/17/1987
Decision Date 09/17/1987
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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