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FDA 510(k), K131596, WOUND MEASURING & MONITORING DEVICE
FDA 510(k), K131596, WOUND MEASURING & MONITORING DEVICE
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510(K) Number: K131596
Device Name: WOUND MEASURING & MONITORING DEVICE
Manufacturer: GRETCHEN MILLER BOWKER
Device Classification Name: Tape, Camera, Surgical
Regulation Number: FXN
Classification Product Code: KXA
Date Received: 06/03/2013
Decision Date: 12/11/2013
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: General & Plastic Surgery
Device Name: WOUND MEASURING & MONITORING DEVICE
Manufacturer: GRETCHEN MILLER BOWKER
Device Classification Name: Tape, Camera, Surgical
Regulation Number: FXN
Classification Product Code: KXA
Date Received: 06/03/2013
Decision Date: 12/11/2013
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: General & Plastic Surgery
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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