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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 K882471
Device Name ITE HEARING AID, EARTECH/CUSTOM AID MODEL CA
Applicant
Ear Tech, Inc.
303 Us Blvd. 301 W #643
Bradenton,  FL  34205
Applicant Contact MARK A KRYWKO
Correspondent
Ear Tech, Inc.
303 Us Blvd. 301 W #643
Bradenton,  FL  34205
Correspondent Contact MARK A KRYWKO
Regulation Number874.3300
Classification Product Code
ESD  
Date Received06/15/1988
Decision Date 08/26/1988
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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