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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Falloposcope
510(k) Number K221965
Device Name FemDx FalloView
Applicant
Femdx Medsystems, Inc.
2336 Walsh Ave.
Suite A
Santa Clara,  CA  95051
Applicant Contact PeiJie Cao
Correspondent
Regulatory Consulting Services, LLC
2336 Walsh Ave.
Suite A
Santa Clara,  CA  95051
Correspondent Contact Sevrina Ciucci
Regulation Number884.1690
Classification Product Code
MKO  
Subsequent Product Code
HIH  
Date Received07/05/2022
Decision Date 03/17/2023
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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