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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Nerve, Transcutaneous, For Pain Relief
510(k) Number K120054
Device Name ULTIMA NEO
Applicant
PAIN MANAGEMENT TECHNOLOGIES
1340 HOME AVE. , BLDG A
AKRON,  OH  44310
Applicant Contact JOSHUA LEFKOVITZ
Correspondent
PAIN MANAGEMENT TECHNOLOGIES
1340 HOME AVE. , BLDG A
AKRON,  OH  44310
Correspondent Contact JOSHUA LEFKOVITZ
Regulation Number882.5890
Classification Product Code
GZJ  
Subsequent Product Codes
IPF   LIH  
Date Received01/06/2012
Decision Date 06/05/2012
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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