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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 K974129
Device Name HI-69E, HI-69N, HI-69P
Applicant
Rockwin Corp.
105 N. First St.
Dekalb,  IL  60115
Applicant Contact KEITH TAYLOR
Correspondent
Rockwin Corp.
105 N. First St.
Dekalb,  IL  60115
Correspondent Contact KEITH TAYLOR
Regulation Number874.3300
Classification Product Code
ESD  
Date Received11/03/1997
Decision Date 12/12/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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