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510(k) K904962

EYE ARTIFICIAL CUSTOM by Midwest Eye Laboratories, Inc. — Product Code HQH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 30, 1991
Date Received
November 5, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Eye, Artificial, Non-Custom
Device Class
Class I
Regulation Number
886.3200
Review Panel
OP
Submission Type

Other clearances by Midwest Eye Laboratories, Inc.

  • K904961 — ARTIFICIAL SCLERAL SHELL (August 30, 1991)

Other clearances for product code HQH

  • K952538 — ROBERT B. SCOTT PLASTIC ARTIFICAL (June 26, 1995)
  • K945270 — CUSTOM ARTIFICIAL HUMAN EYES (May 30, 1995)
  • K946226 — CUSTOM OCULAR PROSTHESIS (March 22, 1995)
  • K923167 — THE NISSEL ARTIFICIAL EYE (September 2, 1992)
  • K791923 — SCLERAL POWDER (January 10, 1980)