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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cannula, Injector, Uterine, Endometrial Biopsy
510(k) Number K133144
Device Name SONOSURE SONOHYSTEROGRAPHY & ENDOMETRIAL SAMPLING DEVICE
Applicant
Crossbay Medical, Inc.
17141 Murphy Ave., Suite 5c
Irvine,  CA  94901
Applicant Contact CINDY DOMECUS
Correspondent
Crossbay Medical, Inc.
17141 Murphy Ave., Suite 5c
Irvine,  CA  94901
Correspondent Contact CINDY DOMECUS
Regulation Number884.4530
Classification Product Code
PGK  
Subsequent Product Code
HFE  
Date Received10/17/2013
Decision Date 03/19/2014
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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