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510(k) K991222

CODMAN MICROSENSOR VENTRICULAR CATHETER KIT by Johnson & Johnson Professionals, Inc. — Product Code GWM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 9, 1999
Date Received
April 12, 1999
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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  • K983014 — SUMMIT ACETABULAR SYSTEM (October 27, 1998)
  • K980778 — HAKIM MICRO PROGRAMMABLE VALVE SYSTEM (July 17, 1998)
  • K974739 — HAKIM PROGRAMMABLE VALVE SYSTEM (July 1, 1998)
  • K980801 — J-FX BIPOLAR HEAD (May 29, 1998)
  • K980081 — S-ROM ZIRCONIA CERAMIC FEMORAL HIP HEAD (April 9, 1998)

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