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510(k) K952538

ROBERT B. SCOTT PLASTIC ARTIFICAL by Robert B. Scott Ocularists of Florida, Inc. — Product Code HQH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 26, 1995
Date Received
May 31, 1995
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 Robert B. Scott Ocularists of Florida, Inc.

  • K772168 — MOLDEYE (November 30, 1977)

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  • 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)
  • K791923 — SCLERAL POWDER (January 10, 1980)