The following data is part of a premarket notification filed by Folsom Metal Products, Inc. with the FDA for Frontier Devices Neuro System.
| Device ID | K100205 |
| 510k Number | K100205 |
| Device Name: | FRONTIER DEVICES NEURO SYSTEM |
| Classification | Plate, Cranioplasty, Preformed, Alterable |
| Applicant | FOLSOM METAL PRODUCTS, INC. 153 CAHABA VALLEY PKWY. Pelham, AL 35124 |
| Contact | Don Peterson |
| Correspondent | Don Peterson FOLSOM METAL PRODUCTS, INC. 153 CAHABA VALLEY PKWY. Pelham, AL 35124 |
| Product Code | GWO |
| Subsequent Product Code | GXR |
| Subsequent Product Code | HBW |
| CFR Regulation Number | 882.5320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-01-25 |
| Decision Date | 2010-12-13 |
| Summary: | summary |