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U.S. Department of Health and Human Services

Establishment Registration & Device Listing
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Classification Name: STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING
Product Code: NIU
Device Class: 3
Registered Establishment Name: COOK IRELAND LTD
Registered Establishment Number: 3001845648
Premarket Submission Number: P100022
Owner/Operator: COOK IRELAND LTD
Owner/Operator Number: 9052427
Establishment Operations: Manufacturer; Complaint File Establishment
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