The following data is part of a premarket notification filed by Ulti-med Intl., Inc. with the FDA for Ulticare Safety Insulin Syringe.
| Device ID | K103011 |
| 510k Number | K103011 |
| Device Name: | ULTICARE SAFETY INSULIN SYRINGE |
| Classification | Syringe, Antistick |
| Applicant | ULTI-MED INTL., INC. 5353 WAYZATA BOULEVARD SUITE 505 Minneapolis, MN 55416 |
| Contact | Mary Beth Henderson |
| Correspondent | Mary Beth Henderson ULTI-MED INTL., INC. 5353 WAYZATA BOULEVARD SUITE 505 Minneapolis, MN 55416 |
| Product Code | MEG |
| Subsequent Product Code | FMF |
| Subsequent Product Code | FMI |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-10-12 |
| Decision Date | 2011-02-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10015482102958 | K103011 | 000 |
| 10015482102910 | K103011 | 000 |
| 20357515032595 | K103011 | 000 |
| 20357515032199 | K103011 | 000 |