510(k) K161812
K161812 is an FDA 510(k) premarket notification submitted by Procedure Products, Inc. for the device "Freedom Syringe". The FDA issued a decision of Substantially Equivalent on March 27, 2017. The device falls under product code FMF (Syringe, Piston), a Class II device regulated under 21 CFR 880.5860. Procedure Products, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 27, 2017
- Date Received
- July 1, 2016
- 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