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FDA 510(k) Application Details - K111441
Device Classification Name
Insufflator, Laparoscopic
More FDA Info for this Device
510(K) Number
K111441
Device Name
Insufflator, Laparoscopic
Applicant
UNIMAX MEDICAL SYSTEMS, INC.
NO. 45, MINSHEN RD.
DANSHUI TOWN
TAIPEI COUNTY 251 TW
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Contact
MICHAEL LEE
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
05/24/2011
Decision Date
08/19/2011
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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