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510(k) K912789

LM-100/200LOW FLOW INSUFFLATOR by Leisegang Medical, Inc. — Product Code HIG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 20, 1991
Date Received
June 25, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Insufflator, Hysteroscopic
Device Class
Class II
Regulation Number
884.1700
Review Panel
OB
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)
  • K913135 — LM-300TWIN (September 18, 1991)
  • K911212 — LM-150HT LIGHT SOURCE (May 23, 1991)
  • K902313 — LM-1Z ZOOM SCOPE (September 4, 1990)
  • K854767 — LM 1000 (January 24, 1986)

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