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U.S. Department of Health and Human Services

Establishment Registration & Device Listing

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Proprietary Name: CoolFlow
Classification Name: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION
Product Code: OAE
Device Class: 3
Registered Establishment Name: HEI INC., ADVANCED MEDICAL DIVISION
Registered Establishment Number: 1721752
Owner/Operator: HEI, Inc.
Owner/Operator Number: 9000621
Establishment Operations: Contract Manufacturer
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