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FDA 510(k), K160331, LigaSure Curved Jaw, Open Sealer/Divider Electrode, LigaSure Curved Jaw Open Reusable Clamp
FDA 510(k), K160331, LigaSure Curved Jaw, Open Sealer/Divider Electrode, LigaSure Curved Jaw Open Reusable Clamp
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510(K) Number: K160331
Device Name: LigaSure Curved Jaw, Open Sealer/Divider Electrode, LigaSure Curved Jaw Open Reusable Clamp
Manufacturer: Hong Zhu
Device Classification Name: Electrosurgical, Cutting & Coagulation & Accessories
Regulation Number: GEI
Classification Product Code: 02/08/2016
Date Received: 08/12/2016
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: General & Plastic Surgery
Device Name: LigaSure Curved Jaw, Open Sealer/Divider Electrode, LigaSure Curved Jaw Open Reusable Clamp
Manufacturer: Hong Zhu
Device Classification Name: Electrosurgical, Cutting & Coagulation & Accessories
Regulation Number: GEI
Classification Product Code: 02/08/2016
Date Received: 08/12/2016
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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