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FDA 510(k), K191280, E-100 Electrosurgical Generator, SynchroSeal
FDA 510(k), K191280, E-100 Electrosurgical Generator, SynchroSeal
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$149.00 USD
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510(K) Number: K191280
Device Name: E-100 Electrosurgical Generator, SynchroSeal
Manufacturer: Melissa Gonzalez
Device Classification Name: System, Surgical, Computer Controlled Instrument
Regulation Number: NAY
Classification Product Code: 05/13/2019
Date Received: 11/14/2019
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: General & Plastic Surgery
Device Name: E-100 Electrosurgical Generator, SynchroSeal
Manufacturer: Melissa Gonzalez
Device Classification Name: System, Surgical, Computer Controlled Instrument
Regulation Number: NAY
Classification Product Code: 05/13/2019
Date Received: 11/14/2019
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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