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U.S. Department of Health and Human Services

Establishment Registration & Device Listing
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Proprietary Name: BoNee Needle
Classification Name: ENDOSCOPIC INJECTION NEEDLE, GASTROENTEROLOGY-UROLOGY
Product Code: FBK
Device Class: 2
Regulation Number: 876.1500
Medical Specialty: Gastroenterology
Registered Establishment Name: COLOPLAST HUNGARY KFT
Registered Establishment Number: 3003814961
Premarket Submission Number: K090217
Owner/Operator: Coloplast Corp.
Owner/Operator Number: 8010144
Establishment Operations: Repackager/Relabeler
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