The following data is part of a premarket notification filed by Omi Manufacturing Pty., Ltd. with the FDA for Omi Retractable Saftey Syringe, Various.
| Device ID | K060971 |
| 510k Number | K060971 |
| Device Name: | OMI RETRACTABLE SAFTEY SYRINGE, VARIOUS |
| Classification | Syringe, Antistick |
| Applicant | OMI MANUFACTURING PTY., LTD. PO BOX 7007 Deerfield, IL 60015 |
| Contact | Daniel Kamm |
| Correspondent | Daniel Kamm OMI MANUFACTURING PTY., LTD. PO 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 | 2006-04-07 |
| Decision Date | 2006-10-24 |
| Summary: | summary |