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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 K132891
Device Name HYDROLYZED COLLAGEN/AG WOUND GEL WITH SILVER
Applicant
The Hymed Group Corp.
1890 Bucknell Dr.
Bethlehem,  PA  18015
Applicant Contact ANITA PETITO
Correspondent
The Hymed Group Corp.
1890 Bucknell Dr.
Bethlehem,  PA  18015
Correspondent Contact ANITA PETITO
Classification Product Code
FRO  
Date Received09/16/2013
Decision Date 06/19/2014
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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