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U.S. Department of Health and Human Services

Establishment Registration & Device Listing

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Proprietary Name: MODULITH SLX-F2 180mm therapy head
Classification Name: LITHOTRIPTOR, EXTRACORPOREAL SHOCK-WAVE, UROLOGICAL
Product Code: LNS
Device Class: 2
Regulation Number: 876.5990
Medical Specialty: Gastroenterology
Registered Establishment Name: STORZ MEDICAL AG
Registered Establishment Number: 9613347
Premarket Submission Number: K072788
Owner/Operator: STORZ MEDICAL AG
Owner/Operator Number: 9028780
Establishment Operations: Manufacturer
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