510(k) K070575
K070575 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 May 29, 2007. 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
- May 29, 2007
- Date Received
- Feb 28, 2007
- Clearance Type
- Traditional
- 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)