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510(k) K904469

EYEOPENER by Kc Medical Industries — Product Code JYJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 28, 1991
Date Received
October 1, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Gauge, Measuring
Device Class
Class I
Regulation Number
874.4420
Review Panel
EN
Submission Type

Other clearances for product code JYJ

  • K884974 — ACCESSORY TO EYEDROP GUIDE (March 24, 1989)
  • K874569 — SUREDROP EYEDROP GUIDE (May 3, 1988)
  • K833606 — IMPLANT MEASURING GAUGE (January 3, 1984)
  • K801938 — RHINOMETER (September 9, 1980)