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510(k) K896198

MAINSTER WIDE FIELD LASER LENS by Ocular Instruments, Inc. — Product Code HJK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 18, 1989
Date Received
October 27, 1989
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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  • K921414 — TROKEL /3 GONIO LASER LENS (November 16, 1992)
  • K914051 — PEDIATRIC VITRECTOMY LENS SET (December 9, 1991)
  • K914117 — LANDERS HIGH REFRACTIVE INDEX VITRECTOMY LENS SET (November 13, 1991)

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