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510(k) K875205

TRI-FLOW CATHETER by Neurodynamics, Inc. — Product Code JXG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 31, 1988
Date Received
December 18, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Shunt, Central Nervous System And Components
Device Class
Class II
Regulation Number
882.5550
Review Panel
NE
Submission Type

Other clearances by Neurodynamics, Inc.

  • K932402 — MODIFICATION TO GHAJAR GUIDE TWIST DRILL (August 5, 1993)
  • K875018 — GHAJAR GUIDE TWIST DRILL (January 28, 1988)
  • K875019 — GHAJAR GUIDE SYSTEM FOR THE PERFORATOR (January 22, 1988)

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