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FDA 510(k) Application Details - K132204
Device Classification Name
Insufflator, Laparoscopic
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510(K) Number
K132204
Device Name
Insufflator, Laparoscopic
Applicant
LEXION MEDICAL, LLC.
4486 TIMBERLINE CT
VADNAIS HEIGHTS, MN 55127 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
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More FDA Info for this Product Code
Date Received
07/16/2013
Decision Date
08/22/2013
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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