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510(k) K895013

COBO TEMPORARY KERATOPROSTHESIS by Ocular Instruments, Inc. — Product Code MLP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 31, 1989
Date Received
August 8, 1989
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.

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  • 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

  • K910828 — LANDERS WIDE FIELD TEMPORARY KERATOPROSTHESIS (August 21, 1991)
  • K902491 — ECKHARDT TEMPORARY KERATOPROSTHESIS (June 26, 1990)
  • K842856 — LANDERS-FOULKS TEMP. KERATOPROSTHESIS (December 18, 1984)