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FDA 510(k) Application Details - K090456
Device Classification Name
Insufflator, Laparoscopic
More FDA Info for this Device
510(K) Number
K090456
Device Name
Insufflator, Laparoscopic
Applicant
LEXION MEDICAL, LLC.
5000 TOWNSHIP PKWY
ST. PAUL, MN 55110 US
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Contact
BERNARD HORWATH
Other 510(k) Applications for this Contact
Regulation Number
884.1730
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Classification Product Code
HIF
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
02/23/2009
Decision Date
08/26/2009
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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