The following data is part of a premarket notification filed by Brainlab, Ag with the FDA for Disposable Reflective Marker Spheres.
| Device ID | K100038 |
| 510k Number | K100038 |
| Device Name: | DISPOSABLE REFLECTIVE MARKER SPHERES |
| Classification | Neurological Stereotaxic Instrument |
| Applicant | BRAINLAB, AG KAPELLENSTRASSE 12 Feldkirchen, DE 85622 |
| Contact | Alexander Schwiersch |
| Correspondent | Alexander Schwiersch BRAINLAB, AG KAPELLENSTRASSE 12 Feldkirchen, DE 85622 |
| Product Code | HAW |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-01-07 |
| Decision Date | 2010-07-14 |
| Summary: | summary |