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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. SETA PLANT
Registered Establishment Number: 9612812
Owner/Operator: TORAY INDUSTRIES, INC. SETA PLANT
Owner/Operator Number: 9021655
Establishment Operations: Manufacturer
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