510(k) K141245
K141245 is an FDA 510(k) premarket notification submitted by Etex Corporation for the device "ETEX MIXING AND DELIVERY SYSTEM". The FDA issued a decision of Substantially Equivalent on July 9, 2014. The device falls under product code FMF (Syringe, Piston), a Class II device regulated under 21 CFR 880.5860. Etex Corporation has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 9, 2014
- Date Received
- May 14, 2014
- 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