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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 K850535
Device Name MITRATHANE DRESSING
Applicant
Mitral Medical , Ltd.
4070 Youngfield St.
Wheat Ridge,  CO  80033
Applicant Contact RENA E TODD
Correspondent
Mitral Medical , Ltd.
4070 Youngfield St.
Wheat Ridge,  CO  80033
Correspondent Contact RENA E TODD
Regulation Number878.4020
Classification Product Code
NAD  
Date Received02/11/1985
Decision Date 06/05/1985
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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