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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 K081835
Device Name ACTICARE IC AND TSE
Applicant
Bioinduction Limited
2300 Mcdermott Rd.
Suite 200-207
Plano,  TX  75025
Applicant Contact KRISTA OAKES
Correspondent
Bioinduction Limited
2300 Mcdermott Rd.
Suite 200-207
Plano,  TX  75025
Correspondent Contact KRISTA OAKES
Regulation Number882.5890
Classification Product Code
GZJ  
Subsequent Product Code
IPF  
Date Received06/27/2008
Decision Date 03/19/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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