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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name catheter, balloon, dilation of cervical canal
510(k) Number K190813
Device Name CrossBay Cervical Dilator Catheter System
Applicant
CrossBay Medical
13240 Evening Creek Drive, Suite 304
San Diego,  CA  92128
Applicant Contact Piush Vidyarthi
Correspondent
Domecus Consulting Services, LLC
1171 Barroihet Drive
Hillsborough,  CA  94010
Correspondent Contact Cindy Domecus
Regulation Number884.4260
Classification Product Code
PON  
Date Received03/29/2019
Decision Date 08/23/2019
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
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