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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 K880454
Device Name AT EASE STRESS PAD
Applicant
Hospital Specialty Co.
7501 Carnegie Ave.
Cleveland,  OH  44103
Applicant Contact ROBERT A MAY
Correspondent
Hospital Specialty Co.
7501 Carnegie Ave.
Cleveland,  OH  44103
Correspondent Contact ROBERT A MAY
Regulation Number876.5920
Classification Product Code
EYQ  
Date Received02/02/1988
Decision Date 06/16/1988
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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