510(k) K151543
K151543 is an FDA 510(k) premarket notification submitted by Micromedics, Inc. (D/B/A Nordson Medical) for the device "Graft Delivery Device with Integrated Stylet". The FDA issued a decision of Substantially Equivalent on Jul 7, 2015. The device falls under product code FMF (Syringe, Piston), a Class II device regulated under 21 CFR 880.5860. Micromedics, Inc. (D/B/A Nordson Medical) has 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jul 7, 2015
- Date Received
- Jun 8, 2015
- Clearance Type
- Special
- 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)