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510(k) K912366

MAINSTER HIGH MAGNIFICATION LASER LENS by Ocular Instruments, Inc. — Product Code HJK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 25, 1991
Date Received
May 29, 1991
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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  • K914051 — PEDIATRIC VITRECTOMY LENS SET (December 9, 1991)
  • K914117 — LANDERS HIGH REFRACTIVE INDEX VITRECTOMY LENS SET (November 13, 1991)

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