510(k) K173385

Graft Delivery, DePuy Synthes by Micromedics, Inc. (D/B/A Nordson Medical) — Product Code FMF

K173385 is an FDA 510(k) premarket notification submitted by Micromedics, Inc. (D/B/A Nordson Medical) for the device "Graft Delivery, DePuy Synthes". The FDA issued a decision of Substantially Equivalent on Nov 30, 2017. 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
Nov 30, 2017
Date Received
Oct 30, 2017
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)