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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Adaptor, Hygiene
510(k) Number K791423
Device Name TOILET TRAINER FOR HANDICAPPED CHILD
Applicant
Kaye Products, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Kaye Products, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number890.5050
Classification Product Code
ILS  
Date Received07/31/1979
Decision Date 08/10/1979
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized
No
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