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510(k) K933976

MANDELKORN SUTURE LYSIS LENS by Ocular Instruments, Inc. — Product Code HJK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 8, 1994
Date Received
August 13, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Lens, Contact, Polymethylmethacrylate, Diagnostic
Device Class
Class II
Regulation Number
886.1385
Review Panel
OP
Submission Type

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  • K910828 — LANDERS WIDE FIELD TEMPORARY KERATOPROSTHESIS (August 21, 1991)

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