510(k) K122416
K122416 is an FDA 510(k) premarket notification submitted by Artiglass Srl for the device "ARTIGLASS L. O.R. GLASS SYRINGE". The FDA issued a decision of Substantially Equivalent on May 3, 2013. The device falls under product code FMF (Syringe, Piston), a Class II device regulated under 21 CFR 880.5860. Artiglass Srl has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 3, 2013
- Date Received
- August 8, 2012
- 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