FDA 510(k) Application Details - K122658

Device Classification Name	More FDA Info for this Device
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 US Other 510(k) Applications for this Company
Contact	LISA PEACOCK Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PCF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/31/2012
Decision Date	12/20/2012
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