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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrosurgical, Cutting & Coagulation & Accessories
510(k) Number K203183
Device Name CoolSeal Trinity (30 cm shaft, 37 cm shaft, and 44 cm shaft)
Applicant
Bolder Surgical, LLC
331 S. 104th St.
Suite 200
Louisville,  CO  80027
Applicant Contact Nicholas Wong
Correspondent
Bolder Surgical, LLC
331 S. 104th St.
Suite 200
Louisville,  CO  80027
Correspondent Contact Nicholas Wong
Regulation Number878.4400
Classification Product Code
GEI  
Date Received10/27/2020
Decision Date 05/06/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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