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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 K821397
Device Name ADULT INCONTINET BRIEF
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 Received05/11/1982
Decision Date 05/24/1982
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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