The following data is part of a premarket notification filed by Escalon Trek Medical with the FDA for Viscous Fluid System.
| Device ID | K963434 |
| 510k Number | K963434 |
| Device Name: | VISCOUS FLUID SYSTEM |
| Classification | Pump, Infusion, Ophthalmic |
| Applicant | ESCALON TREK MEDICAL 822 SWAN DR. Mukwonago, WI 53149 |
| Contact | Ronald L Hueneke |
| Correspondent | Ronald L Hueneke ESCALON TREK MEDICAL 822 SWAN DR. Mukwonago, WI 53149 |
| Product Code | MRH |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-08-30 |
| Decision Date | 1996-11-25 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10853480006249 | K963434 | 000 |
| 10853480006010 | K963434 | 000 |