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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 K170721
Device Name Cut-Vac Lighted Smoke Evacuation Electrosurgical Pencil
Applicant
Precision Surgical, LLC
245 E Warm Springs Rd., #132
Las Vegas,  NV  89119
Applicant Contact Prash Jayaraj
Correspondent
Third Party Review Group, LLC
25 Independence Blvd.
Warren,  NJ  07059
Correspondent Contact DAVE YUNGVIRT
Regulation Number878.4400
Classification Product Code
GEI  
Date Received03/09/2017
Decision Date 04/21/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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