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510(k) K926464

L.C.S.3000 by Cryodyne Technologies, Inc. — Product Code GEH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 24, 1993
Date Received
December 24, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Unit, Cryosurgical, Accessories
Device Class
Class II
Regulation Number
878.4350
Review Panel
SU
Submission Type

Other clearances by Cryodyne Technologies, Inc.

  • K932520 — CALIBRATION GAS (August 19, 1993)
  • K881465 — CRYOBIOLOGICAL FREEZER (April 21, 1988)
  • K881466 — CELL-CULTURE SHAKER (April 18, 1988)
  • K881467 — MICROSCOPE STAGE HEATER (April 18, 1988)
  • K860738 — CTC 30, 40, 1 LIQUID OXYGEN LITERS (August 6, 1986)

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