Home / 510(k) Clearances / K791923

510(k) K791923

SCLERAL POWDER by Ocularists , Ltd. — Product Code HQH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 10, 1980
Date Received
September 26, 1979
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 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)
  • K904962 — EYE ARTIFICIAL CUSTOM (August 30, 1991)