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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.
Classification Namedevice, occlusion, tubal, contraceptive, laparoscopic
Generic Namedevice, occlusion, tubal, contraceptive, laparoscopic
Regulation Number884.5380
ApplicantGyrus ACMI, Inc.
PMA NumberP870076
Supplement NumberS001
Date Received09/01/1995
Decision Date01/02/1996
Product Code
KNH[ Registered Establishments with KNH ]
Advisory Committee Obstetrics/Gynecology
Supplement Typenormal 180 day track
Supplement Reason location change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a change of sterilization facility to the griffith microscience facility in willowbrook, illinois, for the products including the disposable falope-ring applicator kit with 8mm trocan disposable trocar and cannula, (reorder number 005280-901), and disposable falope-ring applicator kit without 8mm trocan disposable trocar and cannula, (reorder number 006889-901).