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U.S. Department of Health and Human Services

Establishment Registration & Device Listing

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Proprietary Name: Inoue Balloon Catheter
Classification Name: CATHETER, PERCUTANEOUS (VALVULOPLASTY)
Product Code: MAD
Device Class: 3
Registered Establishment Name: TORAY INDUSTRIES, INC.
Registered Establishment Number: 9614758
Owner/Operator: TORAY INDUSTRIES, INC.
Owner/Operator Number: 9037937
Establishment Operations: Manufacturer
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