PMA N17511S013
- Device
- HYSKON HYSTEROSCOPY FLUID
- Applicant
- Coopervision Surgical
- PMA number
- N17511
- Supplement
- S013
- Product code
- LTA
- Decision date
- 2000-02-09
- Generic name
- FLUID, HYSTEROSCOPY
- Approval order statement
- The 30-day notice reqeusted the addition of new filling equipment (the instillation and upgrade of the filling line) to the manufacturing facility for the device.
Current openFDA PMA Record#
- Device
- HYSKON HYSTEROSCOPY FLUID
- Applicant
- Coopervision Surgical
- PMA number
- N17511
- Supplement
- S013
- Product code
- LTA
- Generic name
- FLUID, HYSTEROSCOPY
- Decision date
- 2000-02-09
- Decision code
- OK30
- Date received
- 2000-01-10
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- The 30-day notice reqeusted the addition of new filling equipment (the instillation and upgrade of the filling line) to the manufacturing facility for the device.