The following data is part of a premarket notification filed by Surgentec, Llc with the FDA for Graftgun Universal Graft Delivery System.
| Device ID | K180937 |
| 510k Number | K180937 |
| Device Name: | Graftgun Universal Graft Delivery System |
| Classification | Syringe, Piston |
| Applicant | Surgentec, LLC 7601 N Federal Hwy #150A Boca Raton, FL 33487 |
| Contact | Boca Raton |
| Correspondent | Stephen W. Inglese Quality Solutions And Support PO Box 8271 Holland, MI 49422 |
| Product Code | FMF |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-04-10 |
| Decision Date | 2018-05-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00858406007044 | K180937 | 000 |
| 00858406007433 | K180937 | 000 |