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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Curette, Suction, Endometrial (And Accessories)
510(k) Number K192534
Device Name CrossBay Endometrial Tissue Sampler (ETS)
Applicant
Crossbay Medical
13240 Evening Creek Dr., Suite 304
San Diego,  CA  92128
Applicant Contact Piush Vidyarthi
Correspondent
Domecus Consulting Services, LLC
1171 Barroihet Dr.
Hillsborough,  CA  94010
Correspondent Contact Cindy Domecus
Regulation Number884.1175
Classification Product Code
HHK  
Date Received09/16/2019
Decision Date 03/25/2020
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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