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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 K133279
Device Name MEDIHONEY WOUND DRESSINGS
Applicant
Derma Sciences, Inc.
104 Shorting Rd.
Toronto, Orntario,  CA M1S 3S4
Applicant Contact SHARMINI ATHERAY
Correspondent
Derma Sciences, Inc.
104 Shorting Rd.
Toronto, Orntario,  CA M1S 3S4
Correspondent Contact SHARMINI ATHERAY
Classification Product Code
FRO  
Date Received10/24/2013
Decision Date 06/25/2015
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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