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FDA 510(k), K102461, FRACTORA
FDA 510(k), K102461, FRACTORA
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510(K) Number: K102461
Device Name: FRACTORA
Manufacturer: AMIR WALDMAN
Device Classification Name: Electrosurgical, Cutting & Coagulation & Accessories
Regulation Number: GEI
Classification Product Code: 08/27/2010
Date Received: 06/02/2011
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: General & Plastic Surgery
Device Name: FRACTORA
Manufacturer: AMIR WALDMAN
Device Classification Name: Electrosurgical, Cutting & Coagulation & Accessories
Regulation Number: GEI
Classification Product Code: 08/27/2010
Date Received: 06/02/2011
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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