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510(k) K853308

KEATES IRRIGATION/ASPIRATION/VITREOUS CUTTER 5000 by Frigitronics of Connecticut, Inc. — Product Code HQE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 4, 1985
Date Received
August 7, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Instrument, Vitreous Aspiration And Cutting, Ac-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)
  • K834577 — I/A PROBE LINES (May 22, 1984)
  • K840536 — CRYO SURG 5900 (April 23, 1984)
  • K834437 — KEATES IRRIGATION/ASPIRATION/VITREOUS (March 30, 1984)
  • K822599 — KEATES I/A SYSTEM FRIGITRONICS 4000 (October 6, 1982)
  • K811390 — CCS100 CRYOSURGICAL SYSTEM (June 16, 1981)
  • K760742 — CS-76 AND/OR CRYOCARE I (November 3, 1976)

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  • K153168 — Bi-Blade Vitrectomy Cutter (April 29, 2016)
  • K141065 — CONSTELLATION VISION SYSTEM (August 22, 2014)
  • K121675 — VERSAVIT (June 21, 2012)
  • K120170 — PROCARE PLUS VITRECTOMY SYSTEM (May 30, 2012)
  • K102222 — ULTIMATE VIT ENHAMCER (UVE) (April 8, 2011)
  • K033390 — COLIBRI DISPOSABLE VITRECTOMY CUTTER (November 4, 2003)
  • K030948 — VMATE MODEL VMM1000 (June 17, 2003)
  • K023939 — VELOCITY ADVANTAGE (April 17, 2003)