K032242 is an FDA 510(k) clearance for the PERSONNA PLUS SAFETY SCALPEL SYSTEM. This device is classified as a Blade, Scalpel (Class I - General Controls, product code GES).
Submitted by Omi Manufacturing Pty., Ltd. (Deer Field, US). The FDA issued a Cleared decision on September 23, 2003, 64 days after receiving the submission on July 21, 2003.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4800.
| 510(k) Number | K032242 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 21, 2003 |
| Decision Date | September 23, 2003 |
| Days to Decision | 64 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | GES — Blade, Scalpel |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.4800 |