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FDA 510(k) Application Details - K033991
Device Classification Name
Insufflator, Laparoscopic
More FDA Info for this Device
510(K) Number
K033991
Device Name
Insufflator, Laparoscopic
Applicant
PALL MEDICAL
555 THIRTEENTH STREET, N.W.
WASHINGTON, DC 20004 US
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Contact
JONATHAN S KAHAN
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
12/23/2003
Decision Date
01/22/2004
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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