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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Insufflator, Hysteroscopic
510(k) Number K912789
Device Name LM-100/200LOW FLOW INSUFFLATOR
Applicant
Leisegang Medical, Inc.
6401 Congress Ave.
Boca Raton,  FL  33487
Applicant Contact DOUGLAS KWART
Correspondent
Leisegang Medical, Inc.
6401 Congress Ave.
Boca Raton,  FL  33487
Correspondent Contact DOUGLAS KWART
Regulation Number884.1700
Classification Product Code
HIG  
Date Received06/25/1991
Decision Date 09/20/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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