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FDA 510(k), K130191, MINT
FDA 510(k), K130191, MINT
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510(K) Number: K130191
Device Name: MINT
Manufacturer: APRIL LEE
Device Classification Name: Suture, Surgical, Absorbable, Polydioxanone
Regulation Number: NEW
Classification Product Code: 01/25/2013
Date Received: 06/12/2013
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: General & Plastic Surgery
Device Name: MINT
Manufacturer: APRIL LEE
Device Classification Name: Suture, Surgical, Absorbable, Polydioxanone
Regulation Number: NEW
Classification Product Code: 01/25/2013
Date Received: 06/12/2013
Decision Date: Substantially Equivalent (SESE)
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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