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FDA 510(k), K140533, GALAFLEX MESH
FDA 510(k), K140533, GALAFLEX MESH
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510(K) Number: K140533
Device Name: GALAFLEX MESH
Manufacturer: TEPHA, INC.
Device Classification Name: surgical film
Regulation Number: 878.3300
Classification Product Code: OOD
Date Received: 03/04/2014
Decision Date: 05/21/2014
Regulation Medical Specialty: General & Plastic Surgery
Device Name: GALAFLEX MESH
Manufacturer: TEPHA, INC.
Device Classification Name: surgical film
Regulation Number: 878.3300
Classification Product Code: OOD
Date Received: 03/04/2014
Decision Date: 05/21/2014
Regulation Medical Specialty: General & Plastic Surgery
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
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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