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510(k) K897186

LASER IMAGING WORK STATION by Innovision Medical, Inc. — Product Code HJI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 12, 1990
Date Received
December 28, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Lens, Fundus, Hruby, Diagnostic
Device Class
Class I
Regulation Number
886.1395
Review Panel
OP
Submission Type

Other clearances by Innovision Medical, Inc.

  • K890133 — OCULAR CONNECTION MACHINE(TM) (April 12, 1989)

Other clearances for product code HJI

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  • K902138 — STRIPE PROJECTOR (July 5, 1990)
  • K901839 — 60 FUNDUS CAMERA CF-60UV (July 5, 1990)
  • K820223 — OMS QUARTZ INFUSION CONTACT LENS (February 5, 1982)
  • K802971 — LANDERS CONTACT LENS (February 5, 1981)
  • K802927 — SEBESTYEN IRRIGATING CONTACT LENS (February 5, 1981)
  • K760949 — CHARLES IRRIGATING FUNDUS CONTACT LENS (November 11, 1976)