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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Ablation, Microwave And Accessories
510(k) Number K223138
Device Name AB1 Electrosurgical Instrument, Creo Electrosurgical System
Applicant
Creo Medical, Ltd.
Creo House, Unit 2, Beaufort Park Way
Chepstow,  UA NP16 5UH
Applicant Contact Tiffany Powell
Correspondent
Phil Triolo and Associates LC
86 Skycrest Ln
Salt Lake City,  UT  84108
Correspondent Contact Phil Triolo
Regulation Number878.4400
Classification Product Code
NEY  
Date Received10/04/2022
Decision Date 06/26/2023
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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