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510(k) K832385

CRYOPROBES MC-1400-CRYOSURG-CONSOLE by Spembly Medical , Ltd. — Product Code GEH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 12, 1983
Date Received
July 19, 1983
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 Spembly Medical , Ltd.

  • K925129 — SELECTOR (April 23, 1993)
  • K903303 — SPEMBLY MEDICAL 242 CRYOUNIT/SERIES 242 CRYOPROBES (October 11, 1990)
  • K901974 — SELECTOR ULTRASONIC SURGICAL ASPIRATOR (September 5, 1990)
  • K882568 — 130 CRYO UNIT & ASSOC. CRYOPROBES & SPRAY (September 27, 1988)
  • K882962 — SERIES 40 & SERIES 42 CRYOPROBES (R SERIES) (August 8, 1988)
  • K882963 — SPEMBLY MEDICAL 142 CRYO UNIT (August 8, 1988)
  • K874367 — VARIOUS CARDIAC CRYOPROBES HAVING DIA. & COS. DIFF (January 4, 1988)
  • K840497 — OBSTETRIC PULSAR TWO CHANNEL TENS (April 16, 1984)
  • K832334 — CRYOMEDICS 5000 CRYOSURGICAL CONSOLE (August 12, 1983)
  • K831963 — CRYOMEDICS NEUROSTAT (August 12, 1983)

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