FDA 510(k) Application Details - K022417

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

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510(K) Number K022417
Device Name Stimulator, Nerve, Transcutaneous, For Pain Relief
Applicant CARE REHAB AND ORTHOPAEDIC
1124 DOMINION CT.
MCLEAN, VA 22102 US
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Contact CHRISTIAN E HUNT
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Regulation Number 882.5890

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Classification Product Code GZJ
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Date Received 07/24/2002
Decision Date 04/10/2003
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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