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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 K103067
Device Name EXSALT SD7 WOUND DRESSING
Applicant
Exciton Technologies, Inc.
Suite 4232, 10230 Jasper Ave.
Edmonton,  CA T5J 4P6
Applicant Contact ROD PRECHT
Correspondent
Exciton Technologies, Inc.
Suite 4232, 10230 Jasper Ave.
Edmonton,  CA T5J 4P6
Correspondent Contact ROD PRECHT
Classification Product Code
FRO  
Date Received10/18/2010
Decision Date 05/20/2011
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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