The following data is part of a premarket notification filed by Ulti Med, Inc. with the FDA for Ulti Guard Home Insulin Syringe Container.
| Device ID | K021983 |
| 510k Number | K021983 |
| Device Name: | ULTI GUARD HOME INSULIN SYRINGE CONTAINER |
| Classification | Container, Sharps |
| Applicant | ULTI MED, INC. 287 EAST SIXTH ST. St. Paul, MN 55101 |
| Contact | Charles W Erickson |
| Correspondent | Charles W Erickson ULTI MED, INC. 287 EAST SIXTH ST. St. Paul, MN 55101 |
| Product Code | MMK |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-06-18 |
| Decision Date | 2002-09-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20357515093558 | K021983 | 000 |
| 20357515093350 | K021983 | 000 |
| 20357515094593 | K021983 | 000 |
| 20357515094395 | K021983 | 000 |
| 20357515094197 | K021983 | 000 |