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FDA 510(k) Application Details - K162582
Device Classification Name
Insufflator, Laparoscopic
More FDA Info for this Device
510(K) Number
K162582
Device Name
Insufflator, Laparoscopic
Applicant
FISHER & PAYKEL HEALTHCARE
15 MAURICE PAYKEL PLACE, EAST TAMAKI
AUCKLAND 2013 NZ
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Contact
Tina O'Brien
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
09/15/2016
Decision Date
06/23/2017
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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