FDA 510(k) Application Details - K962910

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

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510(K) Number K962910
Device Name Stimulator, Nerve, Transcutaneous, For Pain Relief
Applicant UNI-PATCH, INC.
P.O. BOX 271
1313 WEST GRANT BLVD.
WABASHA, MN 55981-0271 US
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Contact THOMAS O MOORE
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Regulation Number 882.5890

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Classification Product Code GZJ
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Date Received 07/05/1996
Decision Date 09/05/1996
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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