The following data is part of a premarket notification filed by Ultimed, Inc. with the FDA for Ultiguard Home Insulin Pen Needle Dispenser And Sharps Container.
| Device ID | K081449 |
| 510k Number | K081449 |
| Device Name: | ULTIGUARD HOME INSULIN PEN NEEDLE DISPENSER AND SHARPS CONTAINER |
| Classification | Container, Sharps |
| Applicant | ULTIMED, INC. 5353 WAYZATA BLVD. SUITE 505 Minneapolis, MN 55416 -1334 |
| Contact | C. Stamp |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | MMK |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2008-05-23 |
| Decision Date | 2008-06-03 |
| Summary: | summary |