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FDA 510(k) Application Details - K955791
Device Classification Name
Insufflator, Laparoscopic
More FDA Info for this Device
510(K) Number
K955791
Device Name
Insufflator, Laparoscopic
Applicant
W.O.M. WORLD OF MEDICINE, GMBH
1300 I STREET, N.W.
SUITE 900 WEST
WASHIGNTON, DC 20005-3306 US
Other 510(k) Applications for this Company
Contact
ROBERT P REZNICK
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
12/22/1995
Decision Date
12/17/1996
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OB - Obstetrics/Gynecology
Review Advisory Committee
OB - Obstetrics/Gynecology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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