The following data is part of a premarket notification filed by Clarus Medical Systems, Inc. with the FDA for Clarus Endoscopic Discectomy System Sitetrac Model 6000.
| Device ID | K980588 |
| 510k Number | K980588 |
| Device Name: | CLARUS ENDOSCOPIC DISCECTOMY SYSTEM SITETRAC MODEL 6000 |
| Classification | Retractor |
| Applicant | CLARUS MEDICAL SYSTEMS, INC. 1000 BOONE AVENUE NORTH #100 Minneapolis, MN 55427 -8656 |
| Contact | Dale Sappenfield |
| Correspondent | Dale Sappenfield CLARUS MEDICAL SYSTEMS, INC. 1000 BOONE AVENUE NORTH #100 Minneapolis, MN 55427 -8656 |
| Product Code | GAD |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-02-17 |
| Decision Date | 1998-08-18 |
| Summary: | summary |