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510(k) K141368

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 11, 2014
Date Received
May 23, 2014
Clearance Type
Special
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.

  • K123163 — NEUROPACE BURR HOLE COVER MODEL 8110 (January 18, 2013)

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