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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name tape, camera, surgical
510(k) Number K131596
Device Name WOUND MEASURING & MONITORING DEVICE
Applicant
WOUNDVISION, LLC
29 EAST MCCARTY STREET
SUITE 100
INDIANAPOLIS,  IN  46225
Applicant Contact GRETCHEN MILLER BOWKER
Correspondent
WOUNDVISION, LLC
29 EAST MCCARTY STREET
SUITE 100
INDIANAPOLIS,  IN  46225
Correspondent Contact GRETCHEN MILLER BOWKER
Regulation Number878.4160
Classification Product Code
FXN  
Date Received06/03/2013
Decision Date 12/11/2013
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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