The following data is part of a premarket notification filed by Imris, Inc. with the FDA for Symbis Surgical System.
| Device ID | K143420 |
| 510k Number | K143420 |
| Device Name: | SYMBIS Surgical System |
| Classification | Neurological Stereotaxic Instrument |
| Applicant | IMRIS, Inc. 5101 Shady Oak Rd Minnetonka, MN 55343 |
| Contact | Sanjay Shah |
| Correspondent | Sanjay Shah IMRIS, Inc. 5101 Shady Oak Rd Minnetonka, MN 55343 |
| Product Code | HAW |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-11-28 |
| Decision Date | 2015-10-30 |
| Summary: | summary |