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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 K150208
Device Name Dakin's Skin and Wound Cleanser
Applicant
Century Pharmaceuticals, Inc.
10377 Hague Rd.
Indianapolis,  IN  46256
Applicant Contact Stephen Deardorff
Correspondent
Century Pharmaceuticals, Inc.
10377 Hague Rd.
Indianapolis,  IN  46256
Correspondent Contact Stephen Deardorff
Classification Product Code
FRO  
Date Received01/30/2015
Decision Date 07/21/2016
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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