The following data is part of a premarket notification filed by Micromedics Inc. (d/b/a Nordson Medical) with the FDA for Graft Delivery Device With Integrated Stylet.
| Device ID | K151543 |
| 510k Number | K151543 |
| Device Name: | Graft Delivery Device With Integrated Stylet |
| Classification | Syringe, Piston |
| Applicant | Micromedics Inc. (d/b/a Nordson Medical) 1270 Eagan Industrial Rd, Suite 120 St.paul, MN 55121 |
| Contact | Amy L Peterson |
| Correspondent | Amy L Peterson Micromedics Inc. (d/b/a Nordson Medical) 1270 Eagan Industrial Rd, 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 | 2015-06-08 |
| Decision Date | 2015-07-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00815634020634 | K151543 | 000 |
| 10815634020952 | K151543 | 000 |
| 10815634020990 | K151543 | 000 |
| 10815634020891 | K151543 | 000 |
| 10815634020709 | K151543 | 000 |
| 10815634020693 | K151543 | 000 |
| 10815634020686 | K151543 | 000 |
| 10815634020334 | K151543 | 000 |
| 10815634021331 | K151543 | 000 |
| 10815634021324 | K151543 | 000 |
| 10815634021317 | K151543 | 000 |
| 10815634021300 | K151543 | 000 |
| 10815634021294 | K151543 | 000 |
| 10815634020754 | K151543 | 000 |
| 90815634020903 | K151543 | 000 |
| 10815634020464 | K151543 | 000 |
| 20815634020454 | K151543 | 000 |
| 00815634020443 | K151543 | 000 |
| 00815634020436 | K151543 | 000 |
| 00815634020429 | K151543 | 000 |
| 00815634020412 | K151543 | 000 |
| 00815634020405 | K151543 | 000 |
| 00815634020399 | K151543 | 000 |
| 00815634020382 | K151543 | 000 |
| 00815634020375 | K151543 | 000 |
| 00815634020054 | K151543 | 000 |
| 00815634010450 | K151543 | 000 |
| 10815634021140 | K151543 | 000 |