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U.S. Department of Health and Human Services

Establishment Registration & Device Listing
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Proprietary Name: Assura Irrigation Pressplate; Assura Irrigation Set; Assura Ostomy Bag; Coloplast Irrigation Colotip; SenSura Mio Hospital Irrigation Set; SenSura Mio Irrigation Sleeve; Sensura Mio Irrigation Sleeves
Classification Name: IRRIGATOR, OSTOMY
Product Code: EXD
Device Class: 2
Regulation Number: 876.5895
Medical Specialty: Gastroenterology
Registered Establishment Name: COLOPLAST HUNGARY KFT
Registered Establishment Number: 3003814961
Premarket Submission Number: K121833
Owner/Operator: Coloplast Corp.
Owner/Operator Number: 8010144
Establishment Operations: Manufacturer
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