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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 K922572
Device Name 321Q MINIMUM ENERGY TINNITUS SUPPRESSOR
Applicant
MICROBIO-MEDICS, INC.
1710 SHELBY OAKS DR.
SUITE #21
MEMPHIS,  TN  38134
Applicant Contact TIMOTHY D GOOEH
Correspondent
MICROBIO-MEDICS, INC.
1710 SHELBY OAKS DR.
SUITE #21
MEMPHIS,  TN  38134
Correspondent Contact TIMOTHY D GOOEH
Regulation Number874.3400
Classification Product Code
KLW  
Date Received06/01/1992
Decision Date 11/02/1992
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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