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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
510(k) Number K192905
Device Name Creo Electrosurgical System with HS1 Hemostasis Accessory
Applicant
Creo Medical, Ltd.
Creo House, Unit 2, Beaufort Park Way
Chepstow,  GB NP16 5UH
Applicant Contact Leif Geoghegan
Correspondent
Phil Triolo and Associates LC
86 Skycrest Ln.
Salt Lake City,  UT  84108
Correspondent Contact Leif Geoghegan
Regulation Number876.4300
Classification Product Code
KNS  
Date Received10/15/2019
Decision Date 03/19/2020
Decision Substantially Equivalent - Kit (SESK)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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