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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 K911161
Device Name INERPAN(TM) TEMPORARY WOUND DRESSING
Applicant
Laboratories Delalande
Suite 120 Canal Sq.
1054 31st St. NW
Washington,  DC  20007
Applicant Contact JEAN-PIERRE LACLAU
Correspondent
Laboratories Delalande
Suite 120 Canal Sq.
1054 31st St. NW
Washington,  DC  20007
Correspondent Contact JEAN-PIERRE LACLAU
Classification Product Code
MGP  
Date Received03/15/1991
Decision Date 06/27/1991
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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