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U.S. Department of Health and Human Services

Establishment Registration & Device Listing
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Proprietary Name: KVAC Kit; KVAC Kit/LipoGrafter System; Lipografter S Kit
Classification Name: SYRINGE, IRRIGATING (NON DENTAL)
Product Code: KYZ
Device Class: 1
Regulation Number: 880.6960
Medical Specialty: General Hospital
Registered Establishment Name: Sterigenics U.S., LLC
Registered Establishment Number: 1721676
Premarket Submission Number: K050797
Owner/Operator: Sotera Health LLC
Owner/Operator Number: 10029425
Establishment Operations: Contract Sterilizer
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