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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.
 
Trade NameHULKA CLIP FOR TUBAL OCCLUSION
Classification Namedevice, occlusion, tubal, contraceptive
Generic Nametubal occlusion device
Regulation Number884.5380
ApplicantRICHARD WOLF MEDICAL INSTRUMENTS CORP.
PMA NumberP870080
Date Received12/30/1987
Decision Date09/05/1996
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 
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