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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.
 
Trade NameFALOPE RING BAND AND APPLICATOR SYSTEMS
Classification Namedevice, occlusion, tubal, contraceptive
Generic Nametubal occlusion device
Regulation Number884.5380
ApplicantGYRUS ACMI, INC.
PMA NumberP870076
Date Received12/07/1987
Decision Date09/29/1993
Product Code
KNH[ Registered Establishments with KNH ]
Docket Number 93M-0381
Notice Date 11/10/1993
Advisory Committee Obstetrics/Gynecology
Expedited Review Granted? No
Combination Product No
Recalls CDRH Recalls
Supplements: S001 S003 S004 S005 S006 S007 S008 S009 S010 
S011 S012 S013 
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