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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 K232407
Device Name Cautery Protective Actuation System (CPAS)
Applicant
Safer Surgeries Medical Devices, LLC
3883 Rogers Bridge Rd.
Suite 201b
Duluth,  GA  30097
Applicant Contact Rowland Grattan
Correspondent
Secure Biomed Evalutations
7828 Hickory Flat Highway Suite 120
Woodstock,  GA  30188
Correspondent Contact Braddon Linda
Regulation Number878.4400
Classification Product Code
GEI  
Date Received08/10/2023
Decision Date 10/06/2023
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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