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510(k) K020764

NAVIPRO by Kinamed, Inc. — Product Code HAW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 3, 2002
Date Received
March 7, 2002
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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  • K003347 — ORTHOPILOT (February 23, 2001)
  • K994214 — GEM KNEE SYSTEM (July 19, 2000)

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