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510(k) K896589

MANUAL SURGICAL INSTRUMENTS FOR TITAMED ANTWERP by Optik — Product Code LRZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 27, 1989
Date Received
November 21, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Screwdriver, Surgical
Device Class
Class I
Regulation Number
878.4800
Review Panel
SU
Submission Type

Other clearances by Optik

  • K933776 — OPTIK LAPAROSCOPE (March 16, 1994)
  • K926166 — COAST VIDEO ENDOSCOPIC IMAGING SYSTEM (June 1, 1993)
  • K896404 — TITAMED ANTWERP SYSTEM (April 16, 1990)
  • K894557 — LIGHTSCOPE SET (August 7, 1989)
  • K894558 — MINI LIGHTSCOPE SET, LIGHTSCOPE JR. SET (August 7, 1989)

Other clearances for product code LRZ

  • K872490 — 1.1 SCREWDRIVERS (July 23, 1987)
  • K872387 — STANDARD SCREW DRIVER (July 16, 1987)