|
Device | HULKA CLIP FOR TUBAL OCCLUSION |
Generic Name | Laparoscopic contraceptive tubal occlusion device |
Regulation Number | 884.5380 |
Applicant | RICHARD WOLF MEDICAL INSTRUMENTS CORP. 353 CORPORATE WOODS PKWY. VERNON HILLS, IL 60061 |
PMA Number | P870080 |
Supplement Number | S002 |
Date Received | 08/22/2016 |
Decision Date | 10/14/2016 |
Withdrawal Date
|
09/23/2016 |
Product Code |
KNH |
Advisory Committee |
Obstetrics/Gynecology |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Manufacturing process change involving the replacement of a manual cleaning process with an ultrasonic cleaning process. |