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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 K911649
Device Name MITRASHEER TRANSPLANT DRESSING
Applicant
Polymint Industrial Co. , Ltd.
4080 Youngfield St.
Wheat Ridge,  CO  80033
Applicant Contact ANDREW M REED
Correspondent
Polymint Industrial Co. , Ltd.
4080 Youngfield St.
Wheat Ridge,  CO  80033
Correspondent Contact ANDREW M REED
Classification Product Code
MGP  
Date Received04/12/1991
Decision Date 08/07/1991
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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