PMA N17511S015
- Device
- HYSKON HYSTEROSCOPY FLUID 32% (W/V) DEXTRAN 70 IN DEXTROSE
- Applicant
- Coopervision Surgical
- PMA number
- N17511
- Supplement
- S015
- Product code
- LTA
- Decision date
- 2008-05-14
- Generic name
- FLUID, HYSTEROSCOPY
- Approval order statement
- CHANGE TO THE EQUIPMENT USED FOR CAPPING VIALS.
Current openFDA PMA Record#
- Device
- HYSKON HYSTEROSCOPY FLUID 32% (W/V) DEXTRAN 70 IN DEXTROSE
- Applicant
- Coopervision Surgical
- PMA number
- N17511
- Supplement
- S015
- Product code
- LTA
- Generic name
- FLUID, HYSTEROSCOPY
- Decision date
- 2008-05-14
- Decision code
- OK30
- Date received
- 2008-04-08
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGE TO THE EQUIPMENT USED FOR CAPPING VIALS.