The following data is part of a premarket notification filed by Stryker Leibinger Gmbh & Co. Kg - Navigation with the FDA for Navsuite3 Kit.
| Device ID | K150301 |
| 510k Number | K150301 |
| Device Name: | NavSuite3 Kit |
| Classification | Neurological Stereotaxic Instrument |
| Applicant | Stryker Leibinger GmbH & Co. KG - Navigation Boetzinger Strasse 41 Freiburg, DE D-79111 |
| Contact | Robin L Rowe |
| Correspondent | Robin L Rowe Stryker Leibinger GmbH & Co. KG - Navigation Boetzinger Strasse 41 Freiburg, DE D-79111 |
| Product Code | HAW |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-02-06 |
| Decision Date | 2015-07-08 |
| Summary: | summary |