510(k) K050106
K050106 is an FDA 510(k) premarket notification submitted by Novo Nordisk, Inc. for the device "NOVOFINE AUTOCOVER 30G X 8MM". The FDA issued a decision of Substantially Equivalent on Mar 30, 2005. The device falls under product code FMI (Needle, Hypodermic, Single Lumen), a Class II device regulated under 21 CFR 880.5570. Novo Nordisk, Inc. has 14 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Mar 30, 2005
- Date Received
- Jan 18, 2005
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Needle, Hypodermic, Single Lumen
- Device Class
- Class II
- Regulation Number
- 880.5570
- Review Panel
- HO
- Submission Type
- 510(k)