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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
Applicant
Femasys, Inc.
5000 Research Court, Suite 100
Suwanee,  GA  30024
Applicant Contact LISA PEACOCK
Correspondent
Femasys, Inc.
5000 Research Court, Suite 100
Suwanee,  GA  30024
Correspondent 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
Predetermined Change
Control Plan Authorized		 No
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