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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cannula, Manipulator/Injector, Uterine
510(k) Number K142545
Device Name SonoFlow Sonohysterography and Sonohysterosalpingography Device
Applicant
Crossbay Medical, Inc.
793 Sandoval Way
Hayward,  CA  94544
Applicant Contact Piush Vidyarthi
Correspondent
Domecus Consulting Services, LLC
1171 Barroilhet Dr.
Hillsborough,  CA  94010
Correspondent Contact Cindy Domecus
Regulation Number884.4530
Classification Product Code
LKF  
Date Received09/10/2014
Decision Date 03/20/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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