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 |