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FDA 510(k), K170957, ReConnex Pre-Sutured Tendon
FDA 510(k), K170957, ReConnex Pre-Sutured Tendon
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$149.00 USD
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510(K) Number: K170957
Device Name: ReConnex Pre-Sutured Tendon
Manufacturer: AlloSource
Device Classification Name: suture, nonabsorbable, synthetic, polyethylene
Regulation Number: 878.5000
Classification Product Code: GAT
Date Received: 03/31/2017
Decision Date: 03/20/2018
Regulation Medical Specialty: General & Plastic Surgery
Device Name: ReConnex Pre-Sutured Tendon
Manufacturer: AlloSource
Device Classification Name: suture, nonabsorbable, synthetic, polyethylene
Regulation Number: 878.5000
Classification Product Code: GAT
Date Received: 03/31/2017
Decision Date: 03/20/2018
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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