The following data is part of a premarket notification filed by Ruggles Corp. with the FDA for Titanium Mesh.
| Device ID | K903485 |
| 510k Number | K903485 |
| Device Name: | TITANIUM MESH |
| Classification | Plate, Cranioplasty, Preformed, Alterable |
| Applicant | RUGGLES CORP. 38 BILLINGS RD. No. Quincy, MA 02171 |
| Contact | Allan Ruggles |
| Correspondent | Allan Ruggles RUGGLES CORP. 38 BILLINGS RD. No. Quincy, MA 02171 |
| Product Code | GWO |
| CFR Regulation Number | 882.5320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-07-31 |
| Decision Date | 1991-02-21 |