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FDA 510(k) Application Details - K955477
Device Classification Name
Insufflator, Laparoscopic
More FDA Info for this Device
510(K) Number
K955477
Device Name
Insufflator, Laparoscopic
Applicant
HI TEC MEDICAL VERTRIEBS-GMBH FUR INNOVATIVE MEDIZ
JUNKERSTRASSE-1
TUTTLINGEN D-78532 DE
Other 510(k) Applications for this Company
Contact
ULRICH HENZLER
Other 510(k) Applications for this Contact
Regulation Number
884.1730
More FDA Info for this Regulation Number
Classification Product Code
HIF
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
11/30/1995
Decision Date
08/06/1997
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OB - Obstetrics/Gynecology
Review Advisory Committee
OB - Obstetrics/Gynecology
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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