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FDA 510(k), K161092, GalaSHAPE 3D
FDA 510(k), K161092, GalaSHAPE 3D
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510(K) Number: K161092
Device Name: GalaSHAPE 3D
Manufacturer: Tepha, Inc.
Device Classification Name: surgical film
Regulation Number: 878.3300
Classification Product Code: OOD
Date Received: 04/18/2016
Decision Date: 08/23/2016
Regulation Medical Specialty: General & Plastic Surgery
Device Name: GalaSHAPE 3D
Manufacturer: Tepha, Inc.
Device Classification Name: surgical film
Regulation Number: 878.3300
Classification Product Code: OOD
Date Received: 04/18/2016
Decision Date: 08/23/2016
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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