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U.S. Department of Health and Human Services

Establishment Registration & Device Listing
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Proprietary Name: Monarch
Classification Name: CORONARY DRUG-ELUTING STENT
Product Code: NIQ
Device Class: 3
Registered Establishment Name: INSITU TECHNOLOGIES, INC.
Registered Establishment Number: 2134244
Owner/Operator: INSITU TECHNOLOGIES, INC.
Owner/Operator Number: 9032211
Establishment Operations: U.S. Manufacturer of Export Only Devices
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