The following data is part of a premarket notification filed by Ulti Med, Inc. with the FDA for Ultracare Disposable Pen Needles, Models 31 Gauge X3/16, 29 Gauge X 1/2.
| Device ID | K050464 |
| 510k Number | K050464 |
| Device Name: | ULTRACARE DISPOSABLE PEN NEEDLES, MODELS 31 GAUGE X3/16, 29 GAUGE X 1/2 |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | ULTI MED, INC. 5353 WAYZATA BLVD., STE 505 Minneapolis, MN 55414 |
| Contact | Carole Stamp |
| Correspondent | Carole Stamp ULTI MED, INC. 5353 WAYZATA BLVD., STE 505 Minneapolis, MN 55414 |
| Product Code | FMI |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-02-23 |
| Decision Date | 2005-05-11 |
| Summary: | summary |