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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Instrument, Ultrasonic Surgical
510(k) Number K190281
Device Name Ultrasonic Surgical System
Applicant
Medisonic Technology CO
11411 Southern Highlands Pkwy., Suite 300
Las Vegas,  NV  89141
Applicant Contact Reginald Bart-Williams
Correspondent
FDA 510k Consultants, LLC
1100 Del Lago Cir. #104
Palm Beach Gardens,  FL  33410
Correspondent Contact John Gillespy
Classification Product Code
LFL  
Subsequent Product Code
JDX  
Date Received02/11/2019
Decision Date 10/31/2019
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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