The following data is part of a premarket notification filed by Omi Manufacturing Pty., Ltd. with the FDA for Personna Plus Safety Scalpel System.
| Device ID | K032242 |
| 510k Number | K032242 |
| Device Name: | PERSONNA PLUS SAFETY SCALPEL SYSTEM |
| Classification | Blade, Scalpel |
| Applicant | OMI MANUFACTURING PTY., LTD. PO BOX 7007 Deerfield, IL 60015 |
| Contact | Daniel Kamm |
| Product Code | GES |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2003-07-21 |
| Decision Date | 2003-09-23 |
| Summary: | summary |