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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name spirometer, therapeutic (incentive)
510(k) Number K792214
Device Name MODEL TM2-BEHIND-THE-EAR TINNITUS
Applicant
STARKEY LABORATORIES, INC.
803 N. Front St. Suite 3
mchenry,  IL  60050
Correspondent
STARKEY LABORATORIES, INC.
803 N. Front St. Suite 3
mchenry,  IL  60050
Regulation Number868.5690
Classification Product Code
BWF  
Date Received11/02/1979
Decision Date 11/27/1979
Decision substantially equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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