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510(k) K122658

Device
FEMCERV ENDOCERVICAL SAMPLER MODEL 3 SIZES: REF FCV-013, REF FCV-011, REF FCV-009
Applicant
FEMASYS INC.
510(k) number
K122658
Product code
PCF  
Decision
Substantially Equivalent (SESE)
Decision date
2012-12-20
Date received
2012-08-31
Regulation
884.1050
Classification name
Sampler, Endocervical
Medical specialty
Obstetrics/Gynecology
Review panel
Obstetrics/Gynecology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
LISA PEACOCK
Address
5000 Research Ct., Suite 100 Suwanee GA US 30024 30024

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code PCF  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K060320FEMECC ENDOCERVICAL CURETTEFemspec LLC2006-07-28
K882606EURO-MED ENDO-CURETTEBuckman Co., Inc.1988-07-25
K882404KEVOR-CURETTEEuro-Med Intl.1988-07-08
K860796DISPO-URETTERoland J. Zwick, Inc.1986-04-08

Legacy Summary#

summary

FDA Review#

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