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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 K984025
Device Name CARE TENS
Applicant
CARE REHAB, INC.
1124 DOMINION COURT
MCLEAN,  VA  22102
Applicant Contact CHRISTIAN HUNT
Correspondent
CARE REHAB, INC.
1124 DOMINION COURT
MCLEAN,  VA  22102
Correspondent Contact CHRISTIAN HUNT
Regulation Number882.5890
Classification Product Code
GZJ  
Date Received11/12/1998
Decision Date 02/10/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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