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510(k) K012380

MODIFICATION TO: STRYKER NAVIGATION SYSTEM, STRYKER FLUOROSCOPY SYSTEM,VIRTUAL FLUOROSCOPY by Stryker Leibinger — Product Code HAW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 3, 2001
Date Received
July 26, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Neurological Stereotaxic Instrument
Device Class
Class II
Regulation Number
882.4560
Review Panel
NE
Submission Type

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  • K000594 — LOCKING SCREW MANDIBULAR RECONSTRUCTION PLATE (December 8, 2000)
  • K000349 — MOTORIZED MICRO MULTILEAF COLLIMATOR (May 3, 2000)

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