The following data is part of a premarket notification filed by Merit Medical Systems, Inc. with the FDA for Elation Endovenous Laser Procedure Kit Universal Fluid Dispensing Syringe.
| Device ID | K090084 |
| 510k Number | K090084 |
| Device Name: | ELATION ENDOVENOUS LASER PROCEDURE KIT UNIVERSAL FLUID DISPENSING SYRINGE |
| Classification | Powered Laser Surgical Instrument |
| Applicant | MERIT MEDICAL SYSTEMS, INC. 1600 WEST MERIT PKWY. South Jordan, UT 84095 |
| Contact | Susan Scott |
| Correspondent | Susan Scott MERIT MEDICAL SYSTEMS, INC. 1600 WEST MERIT PKWY. South Jordan, UT 84095 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-01-12 |
| Decision Date | 2009-03-06 |
| Summary: | summary |