510(k) K042314
K042314 is an FDA 510(k) premarket notification submitted by Biogen for the device "SYRINGE GRIP FOR THE AVONEX PRE-FILLED SYRINGE". The FDA issued a decision of Substantially Equivalent on November 22, 2004. The device falls under product code FMF (Syringe, Piston), a Class II device regulated under 21 CFR 880.5860. Biogen has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 22, 2004
- Date Received
- August 26, 2004
- 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