The following data is part of a premarket notification filed by Trek Medical Products, Inc. with the FDA for Ophthalmic Fluid Injector.
| Device ID | K882403 |
| 510k Number | K882403 |
| Device Name: | OPHTHALMIC FLUID INJECTOR |
| Classification | Syringe, Piston |
| Applicant | TREK MEDICAL PRODUCTS, INC. P.O. BOX B, 820 SWAN DR. Mukwonago, WI 53149 |
| Contact | Kevin B Sinnett |
| Correspondent | Kevin B Sinnett TREK MEDICAL PRODUCTS, INC. P.O. BOX B, 820 SWAN DR. Mukwonago, WI 53149 |
| Product Code | FMF |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-06-10 |
| Decision Date | 1988-09-09 |