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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 -4896
Applicant Contact ROBERT A MAY
Correspondent
HOSPITAL SPECIALTY CO.
7501 CARNEGIE AVE.
CLEVELAND,  OH  44103 -4896
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
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