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510(k) K791898

OCUTOME MODEL 8000 by Cooper Medical Devices Corp. — Product Code HKP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 30, 1979
Date Received
September 25, 1979
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Instrument, Vitreous Aspiration And Cutting, Battery-Powered
Device Class
Class II
Regulation Number
886.4150
Review Panel
OP
Submission Type

Other clearances by Cooper Medical Devices Corp.

  • K802971 — LANDERS CONTACT LENS (February 5, 1981)
  • K802927 — SEBESTYEN IRRIGATING 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)

Other clearances for product code HKP

  • K952558 — AARON VAC 2 (March 19, 1997)
  • K950056 — THE GRIESHABER AXIAL CUTTER (May 5, 1995)
  • K950287 — UNIVIT PROBE (April 10, 1995)
  • K896622 — VISITEC VITRECTOMY UNIT (April 4, 1990)
  • K890595 — MENTOR ANTERIOR SEGMENT VITRECTOR (April 17, 1989)
  • K832074 — CAVITRON/KELMAN PHACO-EMULSIFIER ASPIRA (August 1, 1983)
  • K822599 — KEATES I/A SYSTEM FRIGITRONICS 4000 (October 6, 1982)
  • K813273 — EMERGENCY POWER PAC (EMPAC) (December 31, 1981)
  • K810152 — X-VEE (March 17, 1981)
  • K801231 — EYE-VAC (July 21, 1980)