The following data is part of a premarket notification filed by Surgentec with the FDA for 3d Graftrasp System.
| Device ID | K201900 |
| 510k Number | K201900 |
| Device Name: | 3D GraftRasp System |
| Classification | Syringe, Piston |
| Applicant | SurGenTec 911 Clint Moore Rd Boca Raton, FL 33847 |
| Contact | Andrew Shoup |
| Correspondent | Andrew Shoup SurGenTec 911 Clint Moore Rd Boca Raton, FL 33847 |
| Product Code | FMF |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-07-08 |
| Decision Date | 2020-09-03 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00858406007709 | K201900 | 000 |
| 00858406007600 | K201900 | 000 |
| 00858406007563 | K201900 | 000 |
| 00858406007075 | K201900 | 000 |