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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.
 
DeviceHULKA CLIP FOR TUBAL OCCLUSION
Classification Namelaparoscopic contraceptive tubal occlusion device
Generic Namelaparoscopic contraceptive tubal occlusion device
Regulation Number884.5380
Applicant
RICHARD 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[ Registered Establishments with KNH ]
Docket Number 97M-0123
Notice Date 04/02/1997
Advisory Committee Obstetrics/Gynecology
Expedited Review Granted? No
Combination Product No
Recalls CDRH Recalls
Approval Order Statement 
Approval for the hulka clip tubal occlusion device and applicator systems.
Supplements: S001 S002 
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