The following data is part of a premarket notification filed by Nomos Corp. with the FDA for Refix(tm) System.
| Device ID | K930279 |
| 510k Number | K930279 |
| Device Name: | REFIX(TM) SYSTEM |
| Classification | Accelerator, Linear, Medical |
| Applicant | NOMOS CORP. 7800 RED RD. SUITE 330-D South Miami, FL 33143 |
| Contact | Harris Targovnik |
| Correspondent | Harris Targovnik NOMOS CORP. 7800 RED RD. SUITE 330-D South Miami, FL 33143 |
| Product Code | IYE |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-01-21 |
| Decision Date | 1993-07-27 |