The following data is part of a premarket notification filed by Micromedics, Inc. (d/b/a Nordson Medical) with the FDA for Graft Delivery, Depuy Synthes.
| Device ID | K173385 |
| 510k Number | K173385 |
| Device Name: | Graft Delivery, DePuy Synthes |
| Classification | Syringe, Piston |
| Applicant | Micromedics, Inc. (d/b/a Nordson MEDICAL) 1270 Eagan Industrial Road, Suite 120 St. Paul, MN 55121 |
| Contact | Kristi Brezinka |
| Correspondent | Kristi Brezinka Micromedics, Inc. (d/b/a Nordson MEDICAL) 1270 Eagan Industrial Road, Suite 120 St. Paul, MN 55121 |
| Product Code | FMF |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-10-30 |
| Decision Date | 2017-11-30 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20815634020621 | K173385 | 000 |