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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Assistive Listening
510(k) Number K904755
Device Name ACOUSTIQ LISTENING DEVICE
Applicant
Krueger Laboratories
1544 W. Mineral Rd.
Tempe,  AZ  85283
Applicant Contact CLARK SHANNON
Correspondent
Krueger Laboratories
1544 W. Mineral Rd.
Tempe,  AZ  85283
Correspondent Contact CLARK SHANNON
Regulation Number874.3320
Classification Product Code
LZI  
Date Received10/19/1990
Decision Date 01/29/1991
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
Predetermined Change
Control Plan Authorized		 No
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