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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, Drug
510(k) Number K140389
Device Name CHLORADERM ANTIMICROBIAL TRANSPARENT THIN FILM DRESSING, 2 3/8 X 2 3/4, 4 X 4 3/4
Applicant
Entrotech Life Sciences, Inc.
755 N Mathilda Ave.
Suite 100
Sunnyvale,  CA  94085
Applicant Contact VALERIE DEFIESTA-NG
Correspondent
Entrotech Life Sciences, Inc.
755 N Mathilda Ave.
Suite 100
Sunnyvale,  CA  94085
Correspondent Contact VALERIE DEFIESTA-NG
Classification Product Code
FRO  
Date Received02/14/2014
Decision Date 11/07/2014
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product Yes
Predetermined Change
Control Plan Authorized		 No
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