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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, Tactile
510(k) Number K813057
Device Name VIBRO-COM COMMUNICATOR #8827
Applicant
Sonic Systems, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Sonic Systems, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Classification Product Code
LRA  
Date Received10/29/1981
Decision Date 12/02/1981
Decision Substantially Equivalent (SESE)
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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