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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name sampler, endocervical
510(k) Number K122658
Device Name FEMCERV ENDOCERVICAL SAMPLER MODEL 3 SIZES: REF FCV-013, REF FCV-011, REF FCV-009
Original Applicant
FEMASYS INC.
5000 research court
suite 100
suwanee,  GA  30024
Original Contact lisa peacock
Regulation Number884.1050
Classification Product Code
PCF  
Date Received08/31/2012
Decision Date 12/20/2012
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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