The following data is part of a premarket notification filed by Ultimed, Inc. with the FDA for Ulticare Disposable Syringe.
| Device ID | K994230 |
| 510k Number | K994230 |
| Device Name: | ULTICARE DISPOSABLE SYRINGE |
| Classification | Syringe, Piston |
| Applicant | ULTIMED, INC. 287 EAST 6TH ST. St. Paul, MN 55101 |
| Contact | Charles W Erickson |
| Correspondent | Charles W Erickson ULTIMED, INC. 287 EAST 6TH ST. St. Paul, MN 55101 |
| Product Code | FMF |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-12-16 |
| Decision Date | 2000-03-24 |
| Summary: | summary |