The following data is part of a premarket notification filed by Ultimed, Inc. with the FDA for Ulticare Disposable Syringe 3 Ml/cc.
| Device ID | K033794 |
| 510k Number | K033794 |
| Device Name: | ULTICARE DISPOSABLE SYRINGE 3 ML/CC |
| Classification | Syringe, Piston |
| Applicant | ULTIMED, INC. 188 SUQUAMISH WAY Laconner, WA 98257 |
| Contact | Ellen G Redding |
| Correspondent | Ellen G Redding ULTIMED, INC. 188 SUQUAMISH WAY Laconner, WA 98257 |
| Product Code | FMF |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-12-05 |
| Decision Date | 2003-12-30 |
| Summary: | summary |