510(k) K932114

Device
TUBAL LUMEN SUPPORT
Applicant
COOK OB/GYN
510(k) number
K932114
Product code
HFJ  
Decision
Substantially Equivalent (SESE)
Decision date
1994-09-27
Date received
1993-05-03
Regulation
884.3650
Classification name
Prosthesis, Fallopian Tube
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
TAMMY BACON
Address
1100 W. Morgan St. P.O. Box 271 Spencer IN US 47460 47460

Source Documents#

510(k) summary PDF

Legacy Summary#

summary

FDA Review#

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