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510(k) K882568

130 CRYO UNIT & ASSOC. CRYOPROBES & SPRAY by Spembly Medical , Ltd. — Product Code GEH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 27, 1988
Date Received
June 22, 1988
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)
  • K882963 — SPEMBLY MEDICAL 142 CRYO UNIT (August 8, 1988)
  • K882962 — SERIES 40 & SERIES 42 CRYOPROBES (R SERIES) (August 8, 1988)
  • K874367 — VARIOUS CARDIAC CRYOPROBES HAVING DIA. & COS. DIFF (January 4, 1988)
  • K840497 — OBSTETRIC PULSAR TWO CHANNEL TENS (April 16, 1984)
  • K832385 — CRYOPROBES MC-1400-CRYOSURG-CONSOLE (September 12, 1983)
  • K831963 — CRYOMEDICS NEUROSTAT (August 12, 1983)
  • K832334 — CRYOMEDICS 5000 CRYOSURGICAL CONSOLE (August 12, 1983)

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