This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.
| Device | HYSKON (32% DEXTRAN 70) |
| Generic Name | Fluid, Hysteroscopy |
| Applicant | COOPERVISION SURGICAL |
| Date Received | 1975-07-07 |
| Decision Date | 1975-09-15 |
| PMA | N17511 |
| Supplement | S |
| Product Code | LTA |
| Advisory Committee | Obstetrics/Gynecology |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | COOPERVISION SURGICAL 95 Corporate Dr. trumbull, CT 06611 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| N17511 | Original Filing | |
| S015 | 2008-04-08 | 30-day Notice |
| S014 | 2001-03-19 | 135 Review Track For 30-day Notice |
| S013 | 2000-01-10 | 30-day Notice |
| S012 | 1997-12-01 | Normal 180 Day Track |
| S011 | 1994-11-10 | Normal 180 Day Track |
| S010 | 1993-11-09 | Normal 180 Day Track |
| S009 | 1991-04-30 | Normal 180 Day Track |
| S008 | 1986-02-03 | |
| S007 | ||
| S006 | 1985-01-11 | |
| S005 | 1984-03-30 | |
| S004 | 1984-03-30 | |
| S003 | 1982-09-10 | |
| S002 | 1982-08-18 | |
| S001 | 1981-04-22 |