510(k) K090162
K090162 is an FDA 510(k) premarket notification submitted by Omrix Biopharmaceuticals , Ltd. for the device "EVICEL APPLICATION DEVICE". The FDA issued a decision of Substantially Equivalent on Feb 20, 2009. The device falls under product code FMF (Syringe, Piston), a Class II device regulated under 21 CFR 880.5860. Omrix Biopharmaceuticals , Ltd. has 2 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Feb 20, 2009
- Date Received
- Jan 22, 2009
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Syringe, Piston
- Device Class
- Class II
- Regulation Number
- 880.5860
- Review Panel
- HO
- Submission Type
- 510(k)