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
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Regulation Number 000.0000

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Classification Product Code LKF
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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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