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FDA 510(k), K132232, MINS NEEDLESCOPIC RESPOSABLE DEVICE SYSTEM
FDA 510(k), K132232, MINS NEEDLESCOPIC RESPOSABLE DEVICE SYSTEM
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510(K) Number: K132232
Device Name: MINS NEEDLESCOPIC RESPOSABLE DEVICE SYSTEM
Manufacturer: ALLAN ALWARD
Device Classification Name: Endoscopic Tissue Approximation Device
Regulation Number: OCW
Classification Product Code: KXA
Date Received: 07/18/2013
Decision Date: 12/04/2013
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Gastroenterology/Urology
Device Name: MINS NEEDLESCOPIC RESPOSABLE DEVICE SYSTEM
Manufacturer: ALLAN ALWARD
Device Classification Name: Endoscopic Tissue Approximation Device
Regulation Number: OCW
Classification Product Code: KXA
Date Received: 07/18/2013
Decision Date: 12/04/2013
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Gastroenterology/Urology
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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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