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U.S. Department of Health and Human Services

Establishment Registration & Device Listing
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Proprietary Name: Soleo Sono, Soleo Stim,, Soleo SonoStim
Classification Name: STIMULATOR, NERVE, TRANSCUTANEOUS, FOR PAIN RELIEF
Product Code: GZJ
Device Class: 2
Regulation Number: 882.5890
Medical Specialty: Neurology
Registered Establishment Name: ZIMMER MEDIZINSYSTEME GMBH
Registered Establishment Number: 8010720
Premarket Submission Number: K121059
Owner/Operator: ZIMMER MEDIZINSYSTEME GMBH
Owner/Operator Number: 8010720
Establishment Operations: Manufacturer
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