The following data is part of a premarket notification filed by Ultimed, Inc. with the FDA for Ultimed Ulticare Safety Syringe.
| Device ID | K080600 |
| 510k Number | K080600 |
| Device Name: | ULTIMED ULTICARE SAFETY SYRINGE |
| Classification | Syringe, Antistick |
| Applicant | ULTIMED, INC. 5353 WAYZATA BLVD. SUITE 505 Minneapolis, MN 55416 -1334 |
| Contact | Carole Stamp |
| Correspondent | Carole Stamp ULTIMED, INC. 5353 WAYZATA BLVD. SUITE 505 Minneapolis, MN 55416 -1334 |
| Product Code | MEG |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-03-03 |
| Decision Date | 2008-06-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00357515999993 | K080600 | 000 |
| 08800117112519 | K080600 | 000 |