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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bandage, Liquid
510(k) Number K083087
Device Name ECOCEL
Applicant
Polichem S.A
7361 Calhoun Place, Suite 500
Rockville,  MD  20855
Applicant Contact HARI NAGARADONA
Correspondent
Polichem S.A
7361 Calhoun Place, Suite 500
Rockville,  MD  20855
Correspondent Contact HARI NAGARADONA
Regulation Number880.5090
Classification Product Code
KMF  
Date Received10/16/2008
Decision Date 08/07/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
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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