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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
Predetermined Change
Control Plan Authorized		 No
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