FDA 510(k) Application Details - K020955

Device Classification Name Stimulator, Nerve

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510(K) Number K020955
Device Name Stimulator, Nerve
Applicant NICOLET BIOMEDICAL, INC.
800 LEVANGER LN.
STOUGHTON, WI 53589 US
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Contact Gary Syring
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Regulation Number 874.1820

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Classification Product Code ETN
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Date Received 03/25/2002
Decision Date 04/17/2002
Decision SESE - SUBST EQUIV
Classification Advisory Committee EN - Ear, Nose, & Throat
Review Advisory Committee EN - Ear, Nose, & Throat
Statement / Summary / Purged Status Summary
Type Abbreviated
Reviewed By Third Party N
Expedited Review



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