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U.S. Department of Health and Human Services

Establishment Registration & Device Listing

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Proprietary Name: SOLARGEN 2100S LASER
Classification Name: SYSTEM, LASER, TRANSMYOCARDIAL REVASCULARIZATION
Product Code: MNO
Device Class: 3
Registered Establishment Name: NEW STAR LASERS, INC.
Registered Establishment Number: 2951571
Owner/Operator: NEW STAR LASERS, INC.
Owner/Operator Number: 9011435
Establishment Operations: Contract Manufacturer; Manufacturer; Repackager/Relabeler; Specification Developer
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