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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 K200298
Device Name ABI Instrument, Creo Electrosurgical System
Applicant
Creo Medical Ltd.
Creo House, Unit 2, Beaufort Park Way
Chepstow,  GB NP16 5UH
Applicant Contact Patrick Burn
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 Received02/06/2020
Decision Date 01/05/2021
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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