FDA 510(k) Application Details - K020437

Device Classification Name Stimulator, Nerve, Transcutaneous, For Pain Relief

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510(K) Number K020437
Device Name Stimulator, Nerve, Transcutaneous, For Pain Relief
Applicant CARE REHAB, INC.
1124 DOMINION COURT
MCLEAN, VA 22102 US
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Contact CHRISTIAN HUNT
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Regulation Number 882.5890

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Classification Product Code GZJ
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Date Received 02/08/2002
Decision Date 03/15/2002
Decision SESE - SUBST EQUIV
Classification Advisory Committee NE - Neurology
Review Advisory Committee NE - Neurology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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