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510(k) K882286

EXPANSION COUPLER & MANUAL DRILL AS ACCESSORY SET by Metatech Corp. — Product Code GWM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 18, 1988
Date Received
June 1, 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

Other clearances by Metatech Corp.

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  • K890865 — HEXASCAN SCANNER HANDPIECE (March 24, 1989)
  • K883541 — METALASER VASCULASE (November 4, 1988)
  • K883881 — MODIFIED MODEL 2001 FIBER OPTICS CATHETER (October 27, 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)
  • K881447 — METATECH METAL MICROCLIP (June 22, 1988)

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