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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 INTERNATIONAL AMERICA INC.
Registered Establishment Number: 1649869
Owner/Operator: TORAY INTERNATIONAL AMERICA INC.
Owner/Operator Number: 2435106
Establishment Operations: Repackager/Relabeler
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