The following data is part of a premarket notification filed by Ultimed Incorporated with the FDA for Ulticare Safety Syringe With Removable Needle.
| Device ID | K140949 |
| 510k Number | K140949 |
| Device Name: | ULTICARE SAFETY SYRINGE WITH REMOVABLE NEEDLE |
| Classification | Syringe, Antistick |
| Applicant | ULTIMED INCORPORATED 5353 WAYZATA BLVD., SUITE 505 Minneapolis, MN 55416 |
| Contact | Mary Beth Henderson |
| Correspondent | Mary Beth Henderson ULTIMED INCORPORATED 5353 WAYZATA BLVD., SUITE 505 Minneapolis, MN 55416 |
| Product Code | MEG |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-04-14 |
| Decision Date | 2015-02-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08800117132586 | K140949 | 000 |
| 08800117132517 | K140949 | 000 |
| 08800117132319 | K140949 | 000 |
| 08800117132234 | K140949 | 000 |
| 08800117132210 | K140949 | 000 |
| 08800117132135 | K140949 | 000 |