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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 K053095
Device Name HONEY ALGINATE DRESSING
Applicant
Derma Sciences Canada, Inc.
104 Shorting Rd.
Toronto, Orntario,  CA M1S 3S4
Applicant Contact SHARMINI ATHERAY
Correspondent
Derma Sciences Canada, Inc.
104 Shorting Rd.
Toronto, Orntario,  CA M1S 3S4
Correspondent Contact SHARMINI ATHERAY
Classification Product Code
FRO  
Date Received11/03/2005
Decision Date 07/12/2007
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product Yes
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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