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FDA 510(k) Application Details - K063546
Device Classification Name
Insufflator, Laparoscopic
More FDA Info for this Device
510(K) Number
K063546
Device Name
Insufflator, Laparoscopic
Applicant
LEXION MEDICAL, LLC.
5000 TOWNSHIP PKWY
ST. PAUL, MN 55110 US
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Contact
DUANE LLOYD
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
11/24/2006
Decision Date
01/10/2007
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OB - Obstetrics/Gynecology
Review Advisory Committee
OB - Obstetrics/Gynecology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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