The following data is part of a premarket notification filed by Howmedica Leibinger, Inc. with the FDA for Marker System For Stereotaxic Navigation.
| Device ID | K961120 |
| 510k Number | K961120 |
| Device Name: | MARKER SYSTEM FOR STEREOTAXIC NAVIGATION |
| Classification | Neurological Stereotaxic Instrument |
| Applicant | HOWMEDICA LEIBINGER, INC. 14540 BELTWOOD PARKWAY EAST Dallas, TX 75244 |
| Contact | Andrew B Rogers |
| Correspondent | Andrew B Rogers HOWMEDICA LEIBINGER, INC. 14540 BELTWOOD PARKWAY EAST Dallas, TX 75244 |
| Product Code | HAW |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-03-21 |
| Decision Date | 1996-05-10 |
| Summary: | summary |