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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 K943280
Device Name PROCEL BURN COVER/PROCEL BURN TREATMENT COVER
Applicant
W.L. Gore & Company, GmbH
Hermann-Oberth-Str.22
85640 Putzbrunn
Putzbrunn,  DE
Applicant Contact TINA ROCHOLL
Correspondent
W.L. Gore & Company, GmbH
Hermann-Oberth-Str.22
85640 Putzbrunn
Putzbrunn,  DE
Correspondent Contact TINA ROCHOLL
Classification Product Code
MGP  
Date Received07/07/1994
Decision Date 08/18/1994
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
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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