510(k) K133021
K133021 is an FDA 510(k) premarket notification submitted by Zimmer Knee Creations, Inc. for the device "MIXING SYRINGE SYSTEM". The FDA issued a decision of Substantially Equivalent on Jan 13, 2014. The device falls under product code FMF (Syringe, Piston), a Class II device regulated under 21 CFR 880.5860. Zimmer Knee Creations, Inc. has 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jan 13, 2014
- Date Received
- Sep 26, 2013
- 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
- 510(k)