FEMCERV ENDOCERVICAL SAMPLER MODEL 3 SIZES: REF FCV-013, REF FCV-011, REF FCV-009


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

Correspodent Contact lisa peacock
Regulation Number 884.1050
Classification Product Code
PCF  
Date Received 08/31/2012
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