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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 K955477
Device Name HI-TEC CO2 INSUFFLATOR TYPE 1300
Applicant
HI TEC MEDICAL VERTRIEBS-GMBH FUR INNOVATIVE MEDIZ
JUNKERSTRASSE-1
TUTTLINGEN,  DE D-78532
Applicant Contact ULRICH HENZLER
Correspondent
HI TEC MEDICAL VERTRIEBS-GMBH FUR INNOVATIVE MEDIZ
JUNKERSTRASSE-1
TUTTLINGEN,  DE D-78532
Correspondent Contact ULRICH HENZLER
Regulation Number884.1730
Classification Product Code
HIF  
Date Received11/30/1995
Decision Date 08/06/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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