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FDA 510(k), K133444, STEALTHSTATION S7 / I7 / FUSION NAVIGATION SYSTEMS, AXIEM NAVIGATION SYSTEM
FDA 510(k), K133444, STEALTHSTATION S7 / I7 / FUSION NAVIGATION SYSTEMS, AXIEM NAVIGATION SYSTEM
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510(K) Number: K133444
Device Name: STEALTHSTATION S7 / I7 / FUSION NAVIGATION SYSTEMS, AXIEM NAVIGATION SYSTEM
Manufacturer: KAYE WAITE
Device Classification Name: Neurological Stereotaxic Instrument
Regulation Number: HAW
Classification Product Code: 11/12/2013
Date Received: 07/25/2014
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Neurology
Device Name: STEALTHSTATION S7 / I7 / FUSION NAVIGATION SYSTEMS, AXIEM NAVIGATION SYSTEM
Manufacturer: KAYE WAITE
Device Classification Name: Neurological Stereotaxic Instrument
Regulation Number: HAW
Classification Product Code: 11/12/2013
Date Received: 07/25/2014
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Neurology
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
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