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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Insufflator, Laparoscopic
510(k) Number K930013
Device Name CO2 INSUFFLATOR 1100
Applicant
HI TEC MEDICAL VERTRIEBS-GMBH FUR INNOVATIVE MEDIZ
WILHELMSTR. 5
TUTTLINGEN,  DE D-7200
Applicant Contact MARQUARDT
Correspondent
HI TEC MEDICAL VERTRIEBS-GMBH FUR INNOVATIVE MEDIZ
WILHELMSTR. 5
TUTTLINGEN,  DE D-7200
Correspondent Contact MARQUARDT
Regulation Number884.1730
Classification Product Code
HIF  
Date Received01/04/1993
Decision Date 04/14/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
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