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U.S. Department of Health and Human Services

Establishment Registration & Device Listing

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Proprietary Name: Passport Balloon Dilatation Catheter; Passport Kit with Encore 26 Inflator
Classification Name: DILATOR, CATHETER, URETERAL
Product Code: EZN
Device Class: 2
Regulation Number: 876.5470
Medical Specialty: Gastroenterology
Registered Establishment Name: Boston Scientific Corp., Marina Bay Cust. Fulfillment Center
Registered Establishment Number: 1225687
Owner/Operator: Boston Scientific Corporation
Owner/Operator Number: 9912058
Establishment Operations: Manufacturer
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