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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Garment, Protective, For Incontinence
510(k) Number K853740
Device Name KAY PLUS ADULT DIAPER
Applicant
Beghin_Say Intl., Inc.
P.O. Box 6236
Lakeland,  FL  33807
Applicant Contact SNIDER
Correspondent
Beghin_Say Intl., Inc.
P.O. Box 6236
Lakeland,  FL  33807
Correspondent Contact SNIDER
Regulation Number876.5920
Classification Product Code
EYQ  
Date Received09/06/1985
Decision Date 10/17/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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