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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/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
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
Date Received12/30/1987
Decision Date09/05/1996
Withdrawal Date 09/23/2016
Product Code KNH 
Docket Number 97M-0123
Notice Date 04/02/1997
Advisory Committee Obstetrics/Gynecology
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR THE HULKA CLIP TUBAL OCCLUSION DEVICE AND APPLICATOR SYSTEMS
Supplements:  S001 S002 
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