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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Collector, Ostomy
510(k) Number K803082
Device Name ADHESIVE PERISTOMAL COVERING W/WO CONN.
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 Number876.5900
Classification Product Code
EXB  
Date Received12/05/1980
Decision Date 12/22/1980
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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