FDA 510(k), K203183, CoolSeal Trinity (30 cm shaft, 37 cm shaft, and 44 cm shaft)

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: KXA
Date Received: 10/27/2020
Decision Date: 05/06/2021
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: General & Plastic Surgery

• Total Pages: 1,259
• Fully Redacted Pages: 99
• Content Pages: 1,160 (Total pages minus fully redacted pages)