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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
Predetermined Change
Control Plan Authorized		 No
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