510(k) K051574
K051574 is an FDA 510(k) premarket notification submitted by Nipro Medical Corp. for the device "NIPRO DISPOSABLE SYRINGE WITH OR WITHOUT NEEDLE". The FDA issued a decision of Substantially Equivalent on August 26, 2005. The device falls under product code FMF (Syringe, Piston), a Class II device regulated under 21 CFR 880.5860. Nipro Medical Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 26, 2005
- Date Received
- June 14, 2005
- 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