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510(k) K880154

METATECH INTRACRANIAL PRESSURE MONITORING SYSTEM by Metatech Corp. — Product Code GWM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 28, 1988
Date Received
January 13, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Monitoring, Intracranial Pressure
Device Class
Class II
Regulation Number
882.1620
Review Panel
NE
Submission Type

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  • K882367 — METATECH MICROCLIP APPLICATOR (August 25, 1988)
  • K882286 — EXPANSION COUPLER & MANUAL DRILL AS ACCESSORY SET (July 18, 1988)

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