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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceHULKA CLIP FOR TUBAL OCCLUSION
Generic NameLaparoscopic contraceptive tubal occlusion device
Regulation Number884.5380
ApplicantRichard Wolf Medical Instruments Corp.
353 Corporate Woods Pkwy.
Vernon Hills, IL 60061
PMA NumberP870080
Supplement NumberS002
Date Received08/22/2016
Decision Date10/14/2016
Withdrawal Date09/23/2016
Product Code KNH 
Advisory Committee Obstetrics/Gynecology
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Manufacturing process change involving the replacement of a manual cleaning process with an ultrasonic cleaning process.
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