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510(k) K910828

LANDERS WIDE FIELD TEMPORARY KERATOPROSTHESIS by Ocular Instruments, Inc. — Product Code MLP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 21, 1991
Date Received
February 27, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Keratoprosthesis, Temporary Implant, Surgical Use
Device Class
Class II
Regulation Number
886.3400
Review Panel
OP
Submission Type

Other clearances by Ocular Instruments, Inc.

  • K014170 — STAURENGHI WIDE FIELD SCANNING LASER LENS (March 4, 2002)
  • K012096 — DISPOSABLE VITRECTOMY LENS (August 24, 2001)
  • K933976 — MANDELKORN SUTURE LYSIS LENS (November 8, 1994)
  • K933264 — RITCH NYLON SUTURE LASER LENS (October 31, 1994)
  • K941420 — 50 DEGREE HRI PRISM LENS (August 29, 1994)
  • K935302 — OSHER SURGICAL GONIO/POSTERIOR POLE LENS (April 1, 1994)
  • K923670 — BYRNE EXPULSIVE LENS (November 16, 1992)
  • K921414 — TROKEL /3 GONIO LASER LENS (November 16, 1992)
  • K914051 — PEDIATRIC VITRECTOMY LENS SET (December 9, 1991)
  • K914117 — LANDERS HIGH REFRACTIVE INDEX VITRECTOMY LENS SET (November 13, 1991)

Other clearances for product code MLP

  • K902491 — ECKHARDT TEMPORARY KERATOPROSTHESIS (June 26, 1990)
  • K895013 — COBO TEMPORARY KERATOPROSTHESIS (October 31, 1989)
  • K842856 — LANDERS-FOULKS TEMP. KERATOPROSTHESIS (December 18, 1984)