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FDA 510(k), K163217, GORE BIO-A Tissue Reinforcement
FDA 510(k), K163217, GORE BIO-A Tissue Reinforcement
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510(K) Number: K163217
Device Name: GORE BIO-A Tissue Reinforcement
Manufacturer: W. L. GORE & ASSOCIATES, INC.
Device Classification Name: mesh, surgical, absorbable, plastic and reconstructive surgery
Regulation Number: 878.3300
Classification Product Code: OXF
Date Received: 11/16/2016
Decision Date: 02/10/2017
Regulation Medical Specialty: General & Plastic Surgery
Device Name: GORE BIO-A Tissue Reinforcement
Manufacturer: W. L. GORE & ASSOCIATES, INC.
Device Classification Name: mesh, surgical, absorbable, plastic and reconstructive surgery
Regulation Number: 878.3300
Classification Product Code: OXF
Date Received: 11/16/2016
Decision Date: 02/10/2017
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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