510(k) K162030
K162030 is an FDA 510(k) premarket notification submitted by Sol-Millennium Medical, Inc. for the device "0.5ml Sol-Care Retractable Safety Syringe with Fixed Needle". The FDA issued a decision of Substantially Equivalent on August 19, 2016. The device falls under product code MEG (Syringe, Antistick), a Class II device regulated under 21 CFR 880.5860. Sol-Millennium Medical, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 19, 2016
- Date Received
- July 22, 2016
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Syringe, Antistick
- Device Class
- Class II
- Regulation Number
- 880.5860
- Review Panel
- HO
- Submission Type