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U.S. Department of Health and Human Services

Establishment Registration & Device Listing
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Proprietary Name: CRE Fixed Wire Esophageal Balloon Dilatation Catheter
Classification Name: DILATOR, ESOPHAGEAL
Product Code: KNQ
Device Class: 2
Regulation Number: 876.5365
Medical Specialty: Gastroenterology
Registered Establishment Name: Boston Scientific Cork Limited
Registered Establishment Number: 9616684
Owner/Operator: Boston Scientific Corporation
Owner/Operator Number: 9912058
Establishment Operations: Manufacturer
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