The following data is part of a premarket notification filed by Micromedics, Inc. with the FDA for Graft Delivery System Model Sa-6115.
| Device ID | K100754 |
| 510k Number | K100754 |
| Device Name: | GRAFT DELIVERY SYSTEM MODEL SA-6115 |
| Classification | Syringe, Piston |
| Applicant | MICROMEDICS, INC. 1270 EAGAN INDUSTRIAL ROAD St Paul, MN 55121 -1385 |
| Contact | Thomas A Lopac |
| Correspondent | Thomas A Lopac MICROMEDICS, INC. 1270 EAGAN INDUSTRIAL ROAD St Paul, MN 55121 -1385 |
| Product Code | FMF |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-03-17 |
| Decision Date | 2010-06-09 |
| Summary: | summary |