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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Interferential Current Therapy
510(k) Number K231575
Device Name Vecttor VT-300
Applicant
Artaflex, Inc.
181 Whitehall Dr.
Markham,  CA L3T 9T1
Applicant Contact Gerry Iuliano
Correspondent
Artaflex, Inc.
181 Whitehall Dr.
Markham,  CA L3T 9T1
Correspondent Contact Gerry Iuliano
Regulation Number882.5890
Classification Product Code
LIH  
Date Received05/31/2023
Decision Date 02/08/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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