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510(k) K131596

WOUND MEASURING & MONITORING DEVICE by Woundvision, LLC — Product Code FXN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 11, 2013
Date Received
June 3, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tape, Camera, Surgical
Device Class
Class I
Regulation Number
878.4160
Review Panel
SU
Submission Type

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  • K962148 — VERGE VIDEOMETER (December 20, 1996)