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510(k) K902491

ECKHARDT TEMPORARY KERATOPROSTHESIS by Dutch Ophthalmic USA, Inc. — Product Code MLP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 26, 1990
Date Received
June 5, 1990
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 Dutch Ophthalmic USA, Inc.

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  • K010082 — D.O.R.C. HARMONY TOTAL TTC VITRECTOMY SYSTEM (March 12, 2001)
  • K983797 — D.O.R.C. HARMONY TOTAL VITRECTOMY SYSTEM (March 3, 1999)
  • K980636 — FIBER OPTIC ENDOILLUMINATION PROBE (May 20, 1998)
  • K973229 — D.O.R.C. HEXON ILLUMINATION SYSTEM (November 25, 1997)
  • K973757 — D.O.R.C. SOLUX LIGHT SOURCE (November 7, 1997)
  • K962135 — D.O.R.C. MICRODIATHERMY SYSTEM (August 29, 1996)
  • K954842 — D.O.R.C. VFI/VFE SYSTEM (April 15, 1996)
  • K940373 — OPHTHALMIC CRYO UNIT (July 18, 1994)

Other clearances for product code MLP

  • K910828 — LANDERS WIDE FIELD TEMPORARY KERATOPROSTHESIS (August 21, 1991)
  • K895013 — COBO TEMPORARY KERATOPROSTHESIS (October 31, 1989)
  • K842856 — LANDERS-FOULKS TEMP. KERATOPROSTHESIS (December 18, 1984)