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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 K897154
Device Name NICOLET DBTE HEARING AID: DIGITAL & PROGRAMMABLE
Applicant
NICOLET INSTRUMENT CORP.
5225 VERONA RD.
MADISON,  WI  53711
Applicant Contact RAYMOND T RIDDLE
Correspondent
NICOLET INSTRUMENT CORP.
5225 VERONA RD.
MADISON,  WI  53711
Correspondent Contact RAYMOND T RIDDLE
Regulation Number874.3300
Classification Product Code
ESD  
Date Received12/26/1989
Decision Date 04/30/1990
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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