The following data is part of a premarket notification filed by Icu Medical, Inc with the FDA for Icu Medical Single-use Syringe.
| Device ID | K070856 |
| 510k Number | K070856 |
| Device Name: | ICU MEDICAL SINGLE-USE SYRINGE |
| Classification | Syringe, Piston |
| Applicant | ICU MEDICAL, INC 4455 ATHERTON DR. Salt Lake City, UT 84123 |
| Contact | Tracy S Best |
| Correspondent | Tracy S Best ICU MEDICAL, INC 4455 ATHERTON DR. Salt Lake City, UT 84123 |
| Product Code | FMF |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-03-28 |
| Decision Date | 2007-10-05 |
| Summary: | summary |