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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Hearing Aid, Air-Conduction, Prescription
510(k) Number K890102
Device Name ITC & ITE HEARING AID, HEAR CLEAR MODELS 1-4
Applicant
Hear Clear, Inc.
4401 Twain Ave. Suite 5
San Diego,  CA  92120
Applicant Contact WARNER GLASSFORD
Correspondent
Hear Clear, Inc.
4401 Twain Ave. Suite 5
San Diego,  CA  92120
Correspondent Contact WARNER GLASSFORD
Regulation Number874.3300
Classification Product Code
ESD  
Date Received01/12/1989
Decision Date 05/11/1989
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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