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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 K162508
Device Name KerraCel Ag Gelling Fiber Silver Dressing
Applicant
Exciton Technologies, Inc.
10230 Jasper Ave., Suite 4147
Edmonton,  CA T5J 4P6
Applicant Contact Melanie Ussyk
Correspondent
Exciton Technologies, Inc.
10230 Jasper Ave., Suite 4147
Edmonton,  CA T5J 4P6
Correspondent Contact Melanie Ussyk
Classification Product Code
FRO  
Date Received09/08/2016
Decision Date 02/13/2017
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
Recalls CDRH Recalls
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