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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 K770826
Device Name POUCH, ILEOSTOMY, ODORPROOF, FEATHERLITE
Applicant
HOWMEDICA CORP.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
HOWMEDICA CORP.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number876.5900
Classification Product Code
FON  
Date Received05/05/1977
Decision Date 06/28/1977
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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