510(k) K132841
K132841 is an FDA 510(k) premarket notification submitted by Zyno Medical, LLC for the device "ZYNO MEDICAL ADMINISTRATION SET". The FDA issued a decision of Substantially Equivalent on January 23, 2014. The device falls under product code FPA (Set, Administration, Intravascular), a Class II device regulated under 21 CFR 880.5440. Zyno Medical, LLC has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 23, 2014
- Date Received
- September 10, 2013
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Set, Administration, Intravascular
- Device Class
- Class II
- Regulation Number
- 880.5440
- Review Panel
- HO
- Submission Type