The following data is part of a premarket notification filed by Vitalcare Group, Inc. with the FDA for Omi Retractable Safety Syringe.
| Device ID | K060109 |
| 510k Number | K060109 |
| Device Name: | OMI RETRACTABLE SAFETY SYRINGE |
| Classification | Syringe, Antistick |
| Applicant | VITALCARE GROUP, INC. P.O. BOX 7007 Deerfield, IL 60015 |
| Contact | Daniel Kamm |
| Correspondent | Daniel Kamm VITALCARE GROUP, INC. P.O. BOX 7007 Deerfield, IL 60015 |
| Product Code | MEG |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-01-13 |
| Decision Date | 2006-05-05 |
| Summary: | summary |