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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name electromyograph, diagnostic
510(k) Number K880573
Device Name MODIFIED NICOLET VIKING SYSTEM
Applicant
NICOLET BIOMEDICAL INSTRUMENTS
5225-4 VERONA RD.
P.O. BOX 4287
MADISON,  WI  53711
Applicant Contact RAYMOND T RIDDLE
Correspondent
NICOLET BIOMEDICAL INSTRUMENTS
5225-4 VERONA RD.
P.O. BOX 4287
MADISON,  WI  53711
Correspondent Contact RAYMOND T RIDDLE
Regulation Number890.1375
Classification Product Code
IKN  
Date Received02/10/1988
Decision Date 03/22/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
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