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FDA 510(k) Application Details - K070783
Device Classification Name
Insufflator, Laparoscopic
More FDA Info for this Device
510(K) Number
K070783
Device Name
Insufflator, Laparoscopic
Applicant
SOPRO
124 GAITHER DRIVE
SUITE 140
MT. LAUREL, NJ 08054 US
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Contact
STEVE SALESKY
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
03/21/2007
Decision Date
12/13/2007
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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