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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameFEMCARE FILSHIE CLIP SYSTEM
Classification Namedevice, occlusion, tubal, contraceptive
Generic Nametubal occlusion
Regulation Number884.5380
ApplicantFEMCARE NIKOMED LIMITED
PMA NumberP920046
Supplement NumberS005
Date Received04/14/2008
Decision Date05/15/2008
Product Code
KNH[ Registered Establishments with KNH ]
Advisory Committee Obstetrics/Gynecology
Supplement Typenormal 180 day track no user fee
Supplement Reason location change: manufacturer
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a manufacturing site located at wesley coe ltd. , england, united kingdom.
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