Approval for the instruction manual "hulka clips for hulka clip applicators" - e36 to be included with each box of clips sold.
Device | HULKA CLIP FOR TUBAL OCCLUSION |
Classification Name | Laparoscopic Contraceptive Tubal Occlusion Device |
Generic Name | Laparoscopic Contraceptive Tubal Occlusion Device |
Applicant | RICHARD WOLF MEDICAL INSTRUMENTS CORP. |
Date Received | 1998-01-09 |
Decision Date | 1998-03-12 |
PMA | P870080 |
Supplement | S001 |
Product Code | KNH |
Advisory Committee | Obstetrics/Gynecology |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
Expedited Review | No |
Combination Product | No |
Applicant Address | RICHARD WOLF MEDICAL INSTRUMENTS CORP. 353 Corporate Woods Pkwy. vernon Hills, IL 60061 |
Supplemental Filings
Supplement Number | Date | Supplement Type |
P870080 | | Original Filing |
S002 |
2016-08-22 |
30-day Notice |
S001 |
1998-01-09 |
Normal 180 Day Track |
NIH GUDID Devices