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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
Gyrus ACMI, Inc.
136 turnpike rd.
southborough, MA 01772
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).