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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 K760277
Device Name UNDERPAD CODE NO. 8453
Applicant
JOHNSON & JOHNSON PROFESSIONALS, INC.
325 PARAMOUNT DR.
RAYNHAM,  MA  02767 -0350
Correspondent
JOHNSON & JOHNSON PROFESSIONALS, INC.
325 PARAMOUNT DR.
RAYNHAM,  MA  02767 -0350
Regulation Number876.5920
Classification Product Code
EYQ  
Date Received07/23/1976
Decision Date 08/11/1976
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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