|
Device | HYSKON HYSTEROSCOPY FLUID |
Generic Name | FLUID, HYSTEROSCOPY |
Applicant | COOPERVISION SURGICAL 95 Corporate Dr. Trumbull, CT 06611 |
PMA Number | N17511 |
Supplement Number | S014 |
Date Received | 03/19/2001 |
Decision Date | 08/17/2001 |
Withdrawal Date
|
04/14/2009 |
Product Code |
LTA |
Advisory Committee |
Obstetrics/Gynecology |
Supplement Type | 135 Review Track For 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
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. |