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U.S. Department of Health and Human Services

Establishment Registration & Device Listing
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Proprietary Name: Therakos CellEx Photopheresis System; UVAR XTS PHOTOPHERESIS SYSTEM
Classification Name: SYSTEM, PHOTOPHERESIS, EXTRACORPOREAL
Product Code: LNR
Device Class: 3
Registered Establishment Name: MACK MOLDING COMPANY
Registered Establishment Number: 3000236920
Premarket Submission Number: P860003
Owner/Operator: MACK MOLDING COMPANY
Owner/Operator Number: 9040779
Establishment Operations: Contract Manufacturer; Remanufacturer
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