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U.S. Department of Health and Human Services

Establishment Registration & Device Listing
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Proprietary Name: CRYO 6; CryoOne
Classification Name: POWERED LASER SURGICAL INSTRUMENT
Product Code: GEX
Device Class: 2
Regulation Number: 878.4810
Medical Specialty: General & Plastic Surgery
Registered Establishment Name: ZIMMER MEDIZINSYSTEME GMBH
Registered Establishment Number: 8010720
Premarket Submission Number: K060395
Owner/Operator: ZIMMER MEDIZINSYSTEME GMBH
Owner/Operator Number: 8010720
Establishment Operations: Manufacturer
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