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510(k) K112093

CRYOMATIC CRYO CONSOLE, DISPOSABLE CRYO PROBE, DISPOSABLE PROBE ADAPTER by Keeler Instruments, Inc. — Product Code HRN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 8, 2011
Date Received
July 22, 2011
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Unit, Cryophthalmic, Ac-Powered
Device Class
Class II
Regulation Number
886.4170
Review Panel
OP
Submission Type

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  • K032087 — KEELER WIDE ANGLE OPHTHALMOSCOPE MODEL 1130-P-5004 (November 26, 2003)
  • K992954 — KEELER CRYO MASTER & PROBES (December 21, 1999)
  • K990257 — KEELER PULSAIR 3000 NON CONTACT TONOMETER (March 25, 1999)
  • K973064 — KEELER TEARSCOPE-PLUS (April 7, 1998)
  • K970029 — KEELER SPECTRA INDIRECT OPHTHALMOSCOPE (April 2, 1997)

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  • K162756 — PHAKOS Disposable Retinal Cryo Probe (May 3, 2017)
  • K160591 — D.O.R.C. Disposable Cryo Probe (January 23, 2017)
  • K131787 — CRYOMATIC MKII CONSOLE, CRYOMATIC MKII PROBES, DISPOSABLE CRYO PROBES (December 23, 2013)
  • K062412 — CRYOMATIC (November 6, 2006)
  • K012821 — D.O.R.C. CRYOSTAR CRYOSURGICAL SYSTEM (October 22, 2001)
  • K992954 — KEELER CRYO MASTER & PROBES (December 21, 1999)
  • K823768 — CLIRANS TE08 HOLLOW FIBER DIALYZER (January 8, 1983)