510(k) K140194
K140194 is an FDA 510(k) premarket notification submitted by Navilyst Medical, Inc. for the device "NAMIC RCS SYRINGE". The FDA issued a decision of Substantially Equivalent on April 14, 2014. The device falls under product code FMF (Syringe, Piston), a Class II device regulated under 21 CFR 880.5860. Navilyst Medical, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 14, 2014
- Date Received
- January 27, 2014
- 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