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FDA 510(k) Application Details - K171611
Device Classification Name
Needle, Assisted Reproduction
More FDA Info for this Device
510(K) Number
K171611
Device Name
Needle, Assisted Reproduction
Applicant
William A. Cook Australia Pty Ltd
95 Brandl Street
Eight Mile Plains 4113 AU
Other 510(k) Applications for this Company
Contact
Gordana Pozvek
Other 510(k) Applications for this Contact
Regulation Number
884.6100
More FDA Info for this Regulation Number
Classification Product Code
MQE
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
06/01/2017
Decision Date
12/15/2017
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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