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510(k) K896404

TITAMED ANTWERP SYSTEM by Optik — Product Code JEY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 16, 1990
Date Received
November 7, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Plate, Bone
Device Class
Class II
Regulation Number
872.4760
Review Panel
DE
Submission Type

Other clearances by Optik

  • K933776 — OPTIK LAPAROSCOPE (March 16, 1994)
  • K926166 — COAST VIDEO ENDOSCOPIC IMAGING SYSTEM (June 1, 1993)
  • K896589 — MANUAL SURGICAL INSTRUMENTS FOR TITAMED ANTWERP (December 27, 1989)
  • K894557 — LIGHTSCOPE SET (August 7, 1989)
  • K894558 — MINI LIGHTSCOPE SET, LIGHTSCOPE JR. SET (August 7, 1989)

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