The following data is part of a premarket notification filed by Clarus Medical Systems, Inc. with the FDA for Clarus Spinepen Model 2126.
| Device ID | K955598 |
| 510k Number | K955598 |
| Device Name: | CLARUS SPINEPEN MODEL 2126 |
| Classification | Endoscope, Neurological |
| Applicant | CLARUS MEDICAL SYSTEMS, INC. 1000 BOONE AVENUE NORTH #100 Minneapolis, MN 55427 -8656 |
| Contact | John Vanden Hoek |
| Correspondent | John Vanden Hoek CLARUS MEDICAL SYSTEMS, INC. 1000 BOONE AVENUE NORTH #100 Minneapolis, MN 55427 -8656 |
| Product Code | GWG |
| CFR Regulation Number | 882.1480 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-12-08 |
| Decision Date | 1996-02-06 |