The following data is part of a premarket notification filed by Nomos Corp. with the FDA for Mayfield-acciss Workstation.
| Device ID | K955397 |
| 510k Number | K955397 |
| Device Name: | MAYFIELD-ACCISS WORKSTATION |
| Classification | Neurological Stereotaxic Instrument |
| Applicant | NOMOS CORP. 2591 WEXFORD BAYNE RD. SUITE 400 Sewickley, PA 15143 |
| Contact | Marvin L Sussman |
| Correspondent | Marvin L Sussman NOMOS CORP. 2591 WEXFORD BAYNE RD. SUITE 400 Sewickley, PA 15143 |
| Product Code | HAW |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-11-24 |
| Decision Date | 1996-04-30 |
| Summary: | summary |