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U.S. Department of Health and Human Services

Establishment Registration & Device Listing

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Proprietary Name: EM-9000
Classification Name: LITHOTRIPTOR, EXTRACORPOREAL SHOCK-WAVE,UROLOGICAL
Product Code: LNS
Device Class: 2
Regulation Number: 876.5990
Medical Specialty: Gastroenterology
Registered Establishment Name: Elite Medical Inc.
Registered Establishment Number: 3008168757
Owner/Operator: Elite Medical Inc.
Owner/Operator Number: 10030991
Establishment Operations: Manufacturer
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