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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.
 
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
Supplement NumberS001
Date Received01/09/1998
Decision Date03/12/1998
Product Code
KNH[ Registered Establishments with KNH ]
Advisory Committee Obstetrics/Gynecology
Supplement Typenormal 180 day track
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the instruction manual "hulka clips for hulka clip applicators" - e36 to be included with each box of clips sold.
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