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U.S. Department of Health and Human Services

Establishment Registration & Device Listing

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Proprietary Name: Celsius Catheter; Celsius RMT Catheter; EZ Steer Catheter
Classification Name: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER
Product Code: OAD
Device Class: 3
Registered Establishment Name: BIOSENSE WEBSTER, INC.
Registered Establishment Number: 9673241
Owner/Operator: BIOSENSE WEBSTER, INC.
Owner/Operator Number: 9044811
Establishment Operations: Manufacturer
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