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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name bag, drainage, with adhesive, ostomy
510(k) Number K801504
Device Name HOLLISTER DRAINAGE POUCH
Applicant
HOLLISTER, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
HOLLISTER, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number876.5900
Classification Product Code
FON  
Date Received06/27/1980
Decision Date 08/12/1980
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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