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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 K943808
Device Name RIONET HM-02
Applicant
Rockwin Corp.
205 N. 2nd St.
Dekalb,  IL  60115
Applicant Contact KEITH TAYLOR
Correspondent
Rockwin Corp.
205 N. 2nd St.
Dekalb,  IL  60115
Correspondent Contact KEITH TAYLOR
Regulation Number874.3300
Classification Product Code
ESD  
Date Received08/04/1994
Decision Date 05/24/1995
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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