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FDA 510(k) Application Details - K020955
Device Classification Name
Stimulator, Nerve
More FDA Info for this Device
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
Other 510(k) Applications for this Contact
Regulation Number
874.1820
More FDA Info for this Regulation Number
Classification Product Code
ETN
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More FDA Info for this Product Code
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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