510(k) K032242
K032242 is an FDA 510(k) premarket notification submitted by Omi Manufacturing Pty., Ltd. for the device "PERSONNA PLUS SAFETY SCALPEL SYSTEM". The FDA issued a decision of Substantially Equivalent on September 23, 2003. The device falls under product code GES (Blade, Scalpel), a Class I device regulated under 21 CFR 878.4800. Omi Manufacturing Pty., Ltd. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 23, 2003
- Date Received
- July 21, 2003
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Blade, Scalpel
- Device Class
- Class I
- Regulation Number
- 878.4800
- Review Panel
- SU
- Submission Type