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FDA 510(k) Application Details - K072753
Device Classification Name
Insufflator, Laparoscopic
More FDA Info for this Device
510(K) Number
K072753
Device Name
Insufflator, Laparoscopic
Applicant
RG MEDICAL USA
468 CRAIGHEAD ST.
NASHVILLE, TN 37204 US
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Contact
WINFRIED REICH
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
09/27/2007
Decision Date
01/25/2008
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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