FDA 510(k) Application Details - K982436

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

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510(K) Number K982436
Device Name Stimulator, Nerve, Transcutaneous, For Pain Relief
Applicant WOODSIDE BIOMEDICAL, INC.
18140 SMOKESIGNAL DR.
SAN DIEGO, CA 92127 US
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Contact CAROL PATTERSON
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Regulation Number 882.5890

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Classification Product Code GZJ
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Date Received 07/14/1998
Decision Date 10/08/1998
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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