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FDA 510(k) Application Details - K221965
Device Classification Name
Falloposcope
More FDA Info for this Device
510(K) Number
K221965
Device Name
Falloposcope
Applicant
FemDx Medsystems, Inc.
2336 Walsh Avenue
Suite A
Santa Clara, CA 95051 US
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Contact
PeiJie Cao
Other 510(k) Applications for this Contact
Regulation Number
000.0000
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Classification Product Code
MKO
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More FDA Info for this Product Code
Date Received
07/05/2022
Decision Date
03/17/2023
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OB - Obstetrics/Gynecology
Review Advisory Committee
OB - Obstetrics/Gynecology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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