PMA N17511S010
- Device
- HYSKON (32% DEXTRAN 70)
- Applicant
- Coopervision Surgical
- PMA number
- N17511
- Supplement
- S010
- Product code
- LTA
- Decision date
- 1995-07-18
- Generic name
- FLUID, HYSTEROSCOPY
- Approval order statement
- APPROVAL FOR REVISED LABELING
Current openFDA PMA Record#
- Device
- HYSKON (32% DEXTRAN 70)
- Applicant
- Coopervision Surgical
- PMA number
- N17511
- Supplement
- S010
- Product code
- LTA
- Generic name
- FLUID, HYSTEROSCOPY
- Decision date
- 1995-07-18
- Decision code
- APPR
- Date received
- 1993-11-09
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR REVISED LABELING