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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 K022417
Device Name CARE STIM
Applicant
Care Rehab and Orthopaedic
1124 Dominion Ct.
Mclean,  VA  22102
Applicant Contact CHRISTIAN E HUNT
Correspondent
Care Rehab and Orthopaedic
1124 Dominion Ct.
Mclean,  VA  22102
Correspondent Contact CHRISTIAN E HUNT
Regulation Number882.5890
Classification Product Code
GZJ  
Date Received07/24/2002
Decision Date 04/10/2003
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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