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FDA 510(k), K203183, CoolSeal Trinity (30 cm shaft, 37 cm shaft, and 44 cm shaft)
FDA 510(k), K203183, CoolSeal Trinity (30 cm shaft, 37 cm shaft, and 44 cm shaft)
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$149.00 USD
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510(K) Number: K203183
Device Name: CoolSeal Trinity (30 cm shaft, 37 cm shaft, and 44 cm shaft)
Manufacturer: Nicholas Wong
Device Classification Name: Electrosurgical, Cutting & Coagulation & Accessories
Regulation Number: GEI
Classification Product Code: 10/27/2020
Date Received: 05/06/2021
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: General & Plastic Surgery
Device Name: CoolSeal Trinity (30 cm shaft, 37 cm shaft, and 44 cm shaft)
Manufacturer: Nicholas Wong
Device Classification Name: Electrosurgical, Cutting & Coagulation & Accessories
Regulation Number: GEI
Classification Product Code: 10/27/2020
Date Received: 05/06/2021
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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