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510(k) K991413

CODMAN ETHISORB DURA PATCH by Johnson & Johnson Professionals, Inc. — Product Code GXQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 13, 2000
Date Received
April 23, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dura Substitute
Device Class
Class II
Regulation Number
882.5910
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)
  • 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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  • K161370 — Durepair Dura Regeneration Matrix (November 2, 2016)
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