510(k) K041344
K041344 is an FDA 510(k) premarket notification submitted by Isotis NV for the device "OPEN BORE SYRINGE". The FDA issued a decision of Substantially Equivalent on July 16, 2004. The device falls under product code FMF (Syringe, Piston), a Class II device regulated under 21 CFR 880.5860. Isotis NV has at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 16, 2004
- Date Received
- May 20, 2004
- Clearance Type
- Abbreviated
- 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