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510(k) K991081

FRAMELESS NEUROMATE by Integrated Surgical Systems, Inc. — Product Code HAW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 25, 1999
Date Received
March 31, 1999
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

Other clearances by Integrated Surgical Systems, Inc.

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  • K960685 — ORTHODOC PREOPERATIVE PLANNER MODEL 500 (January 17, 1997)

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