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FDA 510(k) Application Details - K142700
Device Classification Name
Insufflator, Laparoscopic
More FDA Info for this Device
510(K) Number
K142700
Device Name
Insufflator, Laparoscopic
Applicant
GYNETECH PTY. LTD.
Unit 7, 6-8 Macquarie Drive
Thomastown 3095 AU
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Contact
Kevin MacDonald
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
09/22/2014
Decision Date
12/19/2014
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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