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510(k) K923167

THE NISSEL ARTIFICIAL EYE by Nissel , Ltd. — Product Code HQH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 2, 1992
Date Received
June 29, 1992
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

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  • K904962 — EYE ARTIFICIAL CUSTOM (August 30, 1991)
  • K791923 — SCLERAL POWDER (January 10, 1980)