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U.S. Department of Health and Human Services

Establishment Registration & Device Listing
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Proprietary Name: Optune Treatment Kit; Transducer Array
Classification Name: STIMULATOR, LOW ELECTRIC FIELD, TUMOR TREATMENT
Product Code: NZK
Device Class: 3
Registered Establishment Name: NOVOCURE INC
Registered Establishment Number: 3009306483
Premarket Submission Number: P100034
Owner/Operator: NOVOCURE INC
Owner/Operator Number: 10040460
Establishment Operations: Manufacturer
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