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510(k) K874367

VARIOUS CARDIAC CRYOPROBES HAVING DIA. & COS. DIFF by Spembly Medical , Ltd. — Product Code HQO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 4, 1988
Date Received
October 23, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Unit, Cautery, Thermal, Ac-Powered
Device Class
Class II
Regulation Number
886.4115
Review Panel
OP
Submission Type

Other clearances by Spembly Medical , Ltd.

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  • 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)
  • K840497 — OBSTETRIC PULSAR TWO CHANNEL TENS (April 16, 1984)
  • K832385 — CRYOPROBES MC-1400-CRYOSURG-CONSOLE (September 12, 1983)
  • K832334 — CRYOMEDICS 5000 CRYOSURGICAL CONSOLE (August 12, 1983)
  • K831963 — CRYOMEDICS NEUROSTAT (August 12, 1983)

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