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FDA 510(k) Application Details - K011510
Device Classification Name
Insufflator, Laparoscopic
More FDA Info for this Device
510(K) Number
K011510
Device Name
Insufflator, Laparoscopic
Applicant
WISAP GESELLSCHAFT FUR WISSENSCHAFTL. APP. BAU MBH
RUDOLF-DIESEL-RING 20
SAUERLACH D-82054 DE
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Contact
HORST SEMM
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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
05/16/2001
Decision Date
04/02/2002
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OB - Obstetrics/Gynecology
Review Advisory Committee
OB - Obstetrics/Gynecology
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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