FDA 510(k) Application Details - K963236

Device Classification Name Electrode, Cutaneous

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510(K) Number K963236
Device Name Electrode, Cutaneous
Applicant M & R MFG., INC.
11967 UPPER FREDERICKTOWN
AMITY RD.
FREDERICKTOWN, OH 43019 US
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Contact MARK E DAILEY
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Regulation Number 882.1320

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Classification Product Code GXY
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Date Received 08/19/1996
Decision Date 11/15/1996
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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