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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 K211579
Device Name CoolSeal Trinity (30 cm shaft), CoolSeal Trinity (37 cm shaft), CoolSeal Trinity (44 cm shaft)
Applicant
Bolder Surgical, LLC.
331 S. 104th Street, Suite 200
Louisville,  CO  80027
Applicant Contact Nicholas Wong
Correspondent
Bolder Surgical, LLC.
331 S. 104th Street, Suite 200
Louisville,  CO  80027
Correspondent Contact Nicholas Wong
Regulation Number878.4400
Classification Product Code
GEI  
Date Received05/21/2021
Decision Date 09/07/2021
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
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