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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Hearing Aid, Air-Conduction, Prescription
510(k) Number K873736
Device Name NICOLET DIGITAL TWO PIECE HEARING AID
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 Number874.3300
Classification Product Code
ESD  
Date Received09/15/1987
Decision Date 12/08/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Type Traditional
Reviewed by Third Party No
Combination Product No
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