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510(k) K822599

KEATES I/A SYSTEM FRIGITRONICS 4000 by Frigitronics of Connecticut, Inc. — Product Code HKP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 6, 1982
Date Received
August 27, 1982
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 Frigitronics of Connecticut, Inc.

  • K891282 — MIC-100 WITH CRYOPROBES (June 15, 1989)
  • K872362 — FRIGITRONICS ACC-1000 CAPSULE CUTTER (July 27, 1987)
  • K853308 — KEATES IRRIGATION/ASPIRATION/VITREOUS CUTTER 5000 (October 4, 1985)
  • K834577 — I/A PROBE LINES (May 22, 1984)
  • K840536 — CRYO SURG 5900 (April 23, 1984)
  • K834437 — KEATES IRRIGATION/ASPIRATION/VITREOUS (March 30, 1984)
  • K811390 — CCS100 CRYOSURGICAL SYSTEM (June 16, 1981)
  • K760742 — CS-76 AND/OR CRYOCARE I (November 3, 1976)

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)
  • K813273 — EMERGENCY POWER PAC (EMPAC) (December 31, 1981)
  • K810152 — X-VEE (March 17, 1981)
  • K801231 — EYE-VAC (July 21, 1980)
  • K791898 — OCUTOME MODEL 8000 (October 30, 1979)