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U.S. Department of Health and Human Services

Establishment Registration & Device Listing
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Proprietary Name: Compact Alpha Lithotripter; Compact Sigma Lithotripter
Classification Name: LITHOTRIPTOR, EXTRACORPOREAL SHOCK-WAVE, UROLOGICAL
Product Code: LNS
Device Class: 2
Regulation Number: 876.5990
Medical Specialty: Gastroenterology
Registered Establishment Name: DORNIER MEDTECH GMBH
Registered Establishment Number: 9611388
Premarket Submission Number: K002929
Owner/Operator: DORNIER MEDTECH GMBH
Owner/Operator Number: 8010622
Establishment Operations: Foreign Exporter; Manufacturer
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