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510(k) K123163

NEUROPACE BURR HOLE COVER MODEL 8110 by NeuroPace, Inc. — Product Code GXR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 18, 2013
Date Received
October 9, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cover, Burr Hole
Device Class
Class II
Regulation Number
882.5250
Review Panel
NE
Submission Type

Other clearances by NeuroPace, Inc.

  • K141368 — NEUROPACE BURR HOLE COVER (July 11, 2014)

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  • K140309 — CRANIOPLUG (October 3, 2014)
  • K141368 — NEUROPACE BURR HOLE COVER (July 11, 2014)