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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 K881480
Device Name FIRST AMERICAN, RADIONIC, JKR, MODEL AC
Applicant
Jkr Laboratories, Inc.
10701 W. Kellogg
P.O. Box 12201
Wichita,  KS  67209
Applicant Contact JERRY BLUE
Correspondent
Jkr Laboratories, Inc.
10701 W. Kellogg
P.O. Box 12201
Wichita,  KS  67209
Correspondent Contact JERRY BLUE
Regulation Number874.3300
Classification Product Code
ESD  
Date Received04/05/1988
Decision Date 08/11/1988
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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