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510(k) K974739

HAKIM PROGRAMMABLE VALVE SYSTEM by Johnson & Johnson Professionals, Inc. — Product Code JXG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 1, 1998
Date Received
December 19, 1997
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 Johnson & Johnson Professionals, Inc.

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  • K982379 — SUNDT SLIM-LINE ANEURYSM CLIP APPLIER (December 18, 1998)
  • K982812 — G2 TOTAL HIP SYSTEM FEMORAL STEM (11/13 TAPER) (December 4, 1998)
  • K983141 — CAPITELLO-CONDYLAR TOTAL ELBOW PROSTHESIS (November 6, 1998)
  • K983014 — SUMMIT ACETABULAR SYSTEM (October 27, 1998)
  • K980778 — HAKIM MICRO PROGRAMMABLE VALVE SYSTEM (July 17, 1998)
  • K980801 — J-FX BIPOLAR HEAD (May 29, 1998)
  • K980081 — S-ROM ZIRCONIA CERAMIC FEMORAL HIP HEAD (April 9, 1998)

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