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510(k) K883881

MODIFIED MODEL 2001 FIBER OPTICS CATHETER by Metatech Corp. — Product Code GWM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 27, 1988
Date Received
July 29, 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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  • K883541 — METALASER VASCULASE (November 4, 1988)
  • K883518 — EVENT MARKER & A SECOND PRESSURE TREND OUTPUT (September 22, 1988)
  • K882552 — METATECH ROBINSON BOLT ACCESSORY (September 8, 1988)
  • K882367 — METATECH MICROCLIP APPLICATOR (August 25, 1988)
  • K882286 — EXPANSION COUPLER & MANUAL DRILL AS ACCESSORY SET (July 18, 1988)
  • K881447 — METATECH METAL MICROCLIP (June 22, 1988)

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