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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Nerve
510(k) Number K020955
Device Name NICOLET ELECTROCAUTERY DETECTOR
Applicant
NICOLET BIOMEDICAL, INC.
800 LEVANGER LN.
STOUGHTON,  WI  53589
Applicant Contact Gary Syring
Correspondent
NICOLET BIOMEDICAL, INC.
800 LEVANGER LN.
STOUGHTON,  WI  53589
Correspondent Contact Gary Syring
Regulation Number874.1820
Classification Product Code
ETN  
Date Received03/25/2002
Decision Date 04/17/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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