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FDA 510(k), K151163, Signia Loading Unit, Tri-Staple 2.0 Cartridge
FDA 510(k), K151163, Signia Loading Unit, Tri-Staple 2.0 Cartridge
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$89.00 USD
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510(K) Number: K151163
Device Name: Signia Loading Unit, Tri-Staple 2.0 Cartridge
Manufacturer: Covidien LLC
Device Classification Name: staple, implantable
Regulation Number: 878.4750
Classification Product Code: GDW
Date Received: 05/01/2015
Decision Date: 05/29/2015
Regulation Medical Specialty: General & Plastic Surgery
Device Name: Signia Loading Unit, Tri-Staple 2.0 Cartridge
Manufacturer: Covidien LLC
Device Classification Name: staple, implantable
Regulation Number: 878.4750
Classification Product Code: GDW
Date Received: 05/01/2015
Decision Date: 05/29/2015
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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