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U.S. Department of Health and Human Services

Establishment Registration & Device Listing

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Proprietary Name: Pearl 5.0 Handpiece Delivery System; Pearl 8.0 Handpiece Delivery System; Solargen2100s Ho:YAG Laser System; Sologrip III Handpiece Delivery Sys; TMR2000 Ho:YAG Laser System
Classification Name: SYSTEM, LASER, TRANSMYOCARDIAL REVASCULARIZATION
Product Code: MNO
Device Class: 3
Registered Establishment Name: CARDIOGENESIS CORP.
Registered Establishment Number: 2950727
Owner/Operator: Cardiogenesis Corporation
Owner/Operator Number: 9005077
Establishment Operations: Specification Developer
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