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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name masker, tinnitus
510(k) Number K941834
Device Name AUDITORY CASSETTE
Applicant
LTMLT, INC.
1030 NORTH CROOKS RD.
SUITE P
CLAWSON,  MI  48017
Applicant Contact MICHAEL J LAROUERE
Correspondent
LTMLT, INC.
1030 NORTH CROOKS RD.
SUITE P
CLAWSON,  MI  48017
Correspondent Contact MICHAEL J LAROUERE
Regulation Number874.3400
Classification Product Code
KLW  
Date Received04/13/1994
Decision Date 10/31/1994
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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