FDA 510(k) Application Details - K960170

Device Classification Name Stimulator, Electrical, Evoked Response

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510(K) Number K960170
Device Name Stimulator, Electrical, Evoked Response
Applicant MOBERG MEDICAL, INC.
124 SOUTH MAPLE WAY
AMBLER, PA 19002 US
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Contact LARRY ENGLE
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Regulation Number 882.1870

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Classification Product Code GWF
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Date Received 01/16/1996
Decision Date 03/01/1996
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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