The following data is part of a premarket notification filed by Alcon Laboratories with the FDA for Alcon Fluid Injector.
Device ID | K882723 |
510k Number | K882723 |
Device Name: | ALCON FLUID INJECTOR |
Classification | Actuator, Syringe, Injector Type |
Applicant | ALCON LABORATORIES 6201 SOUTH FREEWAY PO BOX 6600 Fort Worth, TX 76134 -2099 |
Contact | Rebecca G Walker |
Correspondent | Rebecca G Walker ALCON LABORATORIES 6201 SOUTH FREEWAY PO BOX 6600 Fort Worth, TX 76134 -2099 |
Product Code | DQF |
CFR Regulation Number | 870.1670 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-07-01 |
Decision Date | 1988-11-08 |