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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
DeviceFILSHIE CLIP (MARK VI) SYSTEM
Classification Namedevice, occlusion, tubal, contraceptive, laparoscopic
Generic Namedevice, occlusion, tubal, contraceptive, laparoscopic
Regulation Number884.5380
Applicant
FEMCARE LTD.
stuart court, spursholt place, salisbury rd
romsey
hampshire SO516
PMA NumberP920046
Date Received09/10/1992
Decision Date09/05/1996
Product Code
KNH[ Registered Establishments with KNH ]
Docket Number 96M-0463
Notice Date 12/09/1996
Advisory Committee Obstetrics/Gynecology
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the filshie clip system (mark vi). The device is a contraceptive tubal occlusion device (tod).
Supplements: S005 S006 S007 
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