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510(k) K802927

SEBESTYEN IRRIGATING CONTACT LENS by Cooper Medical Devices Corp. — Product Code HJI

K802927 is an FDA 510(k) premarket notification submitted by Cooper Medical Devices Corp. for the device "SEBESTYEN IRRIGATING CONTACT LENS". The FDA issued a decision of Substantially Equivalent on February 5, 1981. The device falls under product code HJI (Lens, Fundus, Hruby, Diagnostic), a Class I device regulated under 21 CFR 886.1395. Cooper Medical Devices Corp. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 5, 1981
Date Received
November 19, 1980
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 Cooper Medical Devices Corp.

  • K802971 — LANDERS CONTACT LENS (February 5, 1981)
  • K801850 — CHARLES PNEUMATIC INTRAOCULAR SCISSORS (September 16, 1980)
  • K801411 — MAY ILLUMINATED/INFUSION PIC (July 21, 1980)
  • K801312 — THE PROTECTORS (June 17, 1980)
  • K800833 — VABRA ASPIRATOR (May 14, 1980)
  • K791898 — OCUTOME MODEL 8000 (October 30, 1979)

Other clearances for product code HJI

  • K923670 — BYRNE EXPULSIVE LENS (November 16, 1992)
  • K901839 — 60 FUNDUS CAMERA CF-60UV (July 5, 1990)
  • K902138 — STRIPE PROJECTOR (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)
  • K760949 — CHARLES IRRIGATING FUNDUS CONTACT LENS (November 11, 1976)

FDA data resources