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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 K852049
Device Name MEDICAL TOILET SEAT
Applicant
Pedro Aleman
11570 Mexico
D.F. Mexico,  MX
Applicant Contact CHAPULTEPEC MORALES
Correspondent
Pedro Aleman
11570 Mexico
D.F. Mexico,  MX
Correspondent Contact CHAPULTEPEC MORALES
Regulation Number890.5050
Classification Product Code
ILS  
Date Received05/08/1985
Decision Date 06/24/1985
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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