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FDA 510(k), K162617, NobleStitch EL
FDA 510(k), K162617, NobleStitch EL
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$149.00 USD
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510(K) Number: K162617
Device Name: NobleStitch EL
Manufacturer: FAYE DUNN
Device Classification Name: Suture, Nonabsorbable, Synthetic, Polypropylene
Regulation Number: GAW
Classification Product Code: 09/20/2016
Date Received: 04/06/2017
Decision Date: SE - With Limitations (SESU)
Regulation Medical Specialty: General & Plastic Surgery
Device Name: NobleStitch EL
Manufacturer: FAYE DUNN
Device Classification Name: Suture, Nonabsorbable, Synthetic, Polypropylene
Regulation Number: GAW
Classification Product Code: 09/20/2016
Date Received: 04/06/2017
Decision Date: SE - With Limitations (SESU)
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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