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510(k) K972398

STEALTHSTATION PASSIVE INSTRUMENT OPTION by Surgical Navigation Technologies, Inc. — Product Code HAW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 16, 1997
Date Received
June 26, 1997
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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  • K992927 — STEALTHSTATION TREATMENT GUIDANCE PLATFORM (December 29, 1999)
  • K993021 — METRX SYSTEM (November 10, 1999)
  • K992354 — SNT IMAGE ANALYSIS SYSTEM (October 12, 1999)
  • K991468 — IMMERGE IMAGE CORRELATION (July 6, 1999)
  • K990214 — FLUORONAV MODULE FOR THE STEALTHSTATION SYSTEM (April 22, 1999)
  • K983670 — STEALTHSTATION SYSTEM (January 14, 1999)
  • K984000 — STEALTHSERVER IMAGE STORAGE AND COMMUNICATION SYSTEM (January 12, 1999)

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