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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name non-absorbable, expandable, hemostatic sponge for temporary internal use
510(k) Number K161020
Device Name XSTAT-12, 3-Pack, XSTAT-12, 1-Pack
Applicant
REVMEDX, INC.
25999 SW CANYON CREEK ROAD
SUITE C
WILSONVILLE,  OR  97070
Applicant Contact AMY K. POINTER
Correspondent
REVMEDX, INC.
25999 SW CANYON CREEK ROAD
SUITE C
WILSONVILLE,  OR  97070
Correspondent Contact AMY K. POINTER
Regulation Number878.4452
Classification Product Code
PGZ  
Date Received04/12/2016
Decision Date 07/28/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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