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510(k) K131787

CRYOMATIC MKII CONSOLE, CRYOMATIC MKII PROBES, DISPOSABLE CRYO PROBES by Keeler, Ltd. — Product Code HRN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 23, 2013
Date Received
June 18, 2013
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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  • K112093 — CRYOMATIC CRYO CONSOLE, DISPOSABLE CRYO PROBE, DISPOSABLE PROBE ADAPTER (December 8, 2011)
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  • 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)