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FDA 510(k) Application Details - K142545
Device Classification Name
Cannula, Manipulator/Injector, Uterine
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510(K) Number
K142545
Device Name
Cannula, Manipulator/Injector, Uterine
Applicant
CrossBay Medical, Inc.
793 Sandoval Way
Hayward, CA 94544 US
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Contact
Piush Vidyarthi
Other 510(k) Applications for this Contact
Regulation Number
000.0000
More FDA Info for this Regulation Number
Classification Product Code
LKF
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
09/10/2014
Decision Date
03/20/2015
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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