PMA P870080S002
- Device
- HULKA CLIP FOR TUBAL OCCLUSION
- Applicant
- Richard Wolf Medical Instruments Corp.
- PMA number
- P870080
- Supplement
- S002
- Product code
- KNH
- Decision date
- 2016-10-14
- Classification
- Laparoscopic Contraceptive Tubal Occlusion Device
- Generic name
- Laparoscopic contraceptive tubal occlusion device
- Approval order statement
- Manufacturing process change involving the replacement of a manual cleaning process with an ultrasonic cleaning process.
Current openFDA PMA Record#
- Device
- HULKA CLIP FOR TUBAL OCCLUSION
- Applicant
- Richard Wolf Medical Instruments Corp.
- PMA number
- P870080
- Supplement
- S002
- Product code
- KNH
- Generic name
- Laparoscopic contraceptive tubal occlusion device
- Decision date
- 2016-10-14
- Decision code
- OK30
- Date received
- 2016-08-22
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Manufacturing process change involving the replacement of a manual cleaning process with an ultrasonic cleaning process.