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510(k) K902138

STRIPE PROJECTOR by Academic Catalyst Corp. — Product Code HJI

K902138 is an FDA 510(k) premarket notification submitted by Academic Catalyst Corp. for the device "STRIPE PROJECTOR". The FDA issued a decision of Substantially Equivalent on July 5, 1990. The device falls under product code HJI (Lens, Fundus, Hruby, Diagnostic), a Class I device regulated under 21 CFR 886.1395.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 5, 1990
Date Received
May 10, 1990
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 for product code HJI

  • K923670 — BYRNE EXPULSIVE LENS (November 16, 1992)
  • K901839 — 60 FUNDUS CAMERA CF-60UV (July 5, 1990)
  • K897186 — LASER IMAGING WORK STATION (March 12, 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)

FDA data resources