510(k) K032425
K032425 is an FDA 510(k) premarket notification submitted by Biogen for the device "INVISIJECT RESUSABLE AUTO-INJECTOR". The FDA issued a decision of Substantially Equivalent on November 5, 2003. The device falls under product code KZH (Introducer, Syringe Needle), a Class II device regulated under 21 CFR 880.6920. Biogen has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 5, 2003
- Date Received
- August 6, 2003
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Introducer, Syringe Needle
- Device Class
- Class II
- Regulation Number
- 880.6920
- Review Panel
- HO
- Submission Type