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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 K233185
Device Name MODEL P8400 Controller for C2DX’s Hemostatix Thermal Scalpel System
Applicant
C2dx, Inc.
555 E Eliza St.
Schoolcraft,  MI  49087
Applicant Contact Brad Beale
Correspondent
C2dx, Inc.
555 E Eliza St.
Schoolcraft,  MI  49087
Correspondent Contact Brad Beale
Regulation Number878.4400
Classification Product Code
GEI  
Date Received09/28/2023
Decision Date 10/24/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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