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U.S. Department of Health and Human Services

Establishment Registration & Device Listing

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Proprietary Name: HeartLight (EAS-AC) Cardiac Ablation System
Classification Name: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION
Product Code: OAE
Device Class: 3
Registered Establishment Name: CARDIOFOCUS, INC.
Registered Establishment Number: 1225698
Owner/Operator: CARDIOFOCUS, INC.
Owner/Operator Number: 9026178
Establishment Operations: U.S. Manufacturer of Export Only Devices
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