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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 K090791
Device Name DAKIN'S ANTIMICROBIAL WOUND CLEANSER, MODEL 0.0125% TO 5%
Applicant
Century Pharmaceuticals, Inc.
24301 Woodsage Dr.
Bonita Springs,  FL  34134
Applicant Contact PAUL DRYDEN
Correspondent
Century Pharmaceuticals, Inc.
24301 Woodsage Dr.
Bonita Springs,  FL  34134
Correspondent Contact PAUL DRYDEN
Classification Product Code
FRO  
Date Received03/24/2009
Decision Date 08/07/2009
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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