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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Protector, Wound, Plastic
510(k) Number K904389
Device Name SI-PRO
Applicant
David F. Trungale
16720 Rosewood Ct.
Brookfield,  WI  53005
Applicant Contact DAVID F TRUNAGLE
Correspondent
David F. Trungale
16720 Rosewood Ct.
Brookfield,  WI  53005
Correspondent Contact DAVID F TRUNAGLE
Regulation Number878.4014
Classification Product Code
EYF  
Date Received09/26/1990
Decision Date 12/17/1990
Decision Substantially Equivalent (SESE)
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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