PMA N17511S014
- Device
- HYSKON HYSTEROSCOPY FLUID
- Applicant
- Coopervision Surgical
- PMA number
- N17511
- Supplement
- S014
- Product code
- LTA
- Decision date
- 2001-08-17
- Generic name
- FLUID, HYSTEROSCOPY
- Approval order statement
- APPROVAL FOR THE ADDITION OF A NEW WATER FOR INJECTION(WFI) GENERATION SYSTEM FOR THE WFI COMPONENT OF THE HYSKON(R) HYSTEROSCOPY FLUID.
Current openFDA PMA Record#
- Device
- HYSKON HYSTEROSCOPY FLUID
- Applicant
- Coopervision Surgical
- PMA number
- N17511
- Supplement
- S014
- Product code
- LTA
- Generic name
- FLUID, HYSTEROSCOPY
- Decision date
- 2001-08-17
- Decision code
- APPR
- Date received
- 2001-03-19
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR THE ADDITION OF A NEW WATER FOR INJECTION(WFI) GENERATION SYSTEM FOR THE WFI COMPONENT OF THE HYSKON(R) HYSTEROSCOPY FLUID.