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510(k) K854767

LM 1000 by Leisegang Medical, Inc. — Product Code GEH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 24, 1986
Date Received
November 27, 1985
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 Leisegang Medical, Inc.

  • K990043 — SMOOTHLASE ALEXANDRITE LASER SYSTEM (February 11, 1999)
  • K940094 — COLPOSCOPES AND ACCESSORIES (April 25, 1995)
  • K924134 — LEISEGANG LAPAROSCOPIC IRRIGATION SYSTEM/ACCESS (July 2, 1993)
  • K920217 — MAX-E-VAC (July 23, 1992)
  • K914201 — LM- LAP 10 HIGH FLOW INSUFFLATOR (January 9, 1992)
  • K912789 — LM-100/200LOW FLOW INSUFFLATOR (September 20, 1991)
  • K913135 — LM-300TWIN (September 18, 1991)
  • K911212 — LM-150HT LIGHT SOURCE (May 23, 1991)
  • K902313 — LM-1Z ZOOM SCOPE (September 4, 1990)

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