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U.S. Department of Health and Human Services

Establishment Registration & Device Listing
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Proprietary Name: Durasphere Injectable Bulking Agent
Classification Name: AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE
Product Code: LNM
Device Class: 3
Registered Establishment Name: CARBON MEDICAL TECHNOLOGIES, INC.
Registered Establishment Number: 2134494
Owner/Operator: CARBON MEDICAL TECHNOLOGIES, INC.
Owner/Operator Number: 9034784
Establishment Operations: Manufacturer
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