Home / 510(k) Clearances / K813273

510(k) K813273

EMERGENCY POWER PAC (EMPAC) by Optical Micro Systems, Inc. — Product Code HKP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 31, 1981
Date Received
November 20, 1981
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 Optical Micro Systems, Inc.

  • K950218 — OMS SLIMLINE PHACO HANDPIECE (July 17, 1995)
  • K946054 — DIPLOMAX (July 11, 1995)
  • K935223 — OPHTHALMIC SURGICAL SYSTEM (March 14, 1994)
  • K935226 — I/V POLE (February 16, 1994)
  • K935003 — ELECTRIC I/V POLE OR EIVP2 (January 25, 1994)
  • K870068 — ASPIRATION REVERSAL CONTROL (ARC) MODULE (February 12, 1987)
  • K844373 — O.M.S. ULTRA-PHACO (December 19, 1985)
  • K844448 — OMS/GONVERS RETINAL PERFORATOR (August 21, 1985)
  • K844895 — OMS SILICONE OIL INJECTOR (June 24, 1985)
  • K844467 — OMS CRYO (February 22, 1985)

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)
  • K810152 — X-VEE (March 17, 1981)
  • K801231 — EYE-VAC (July 21, 1980)
  • K791898 — OCUTOME MODEL 8000 (October 30, 1979)