The following data is part of a premarket notification filed by Clarus Medical Systems, Inc. with the FDA for Clarus Models 1100, 1101, 1102, 1103 Laser Disc.
| Device ID | K922881 |
| 510k Number | K922881 |
| Device Name: | CLARUS MODELS 1100, 1101, 1102, 1103 LASER DISC |
| Classification | Powered Laser Surgical Instrument |
| Applicant | CLARUS MEDICAL SYSTEMS, INC. 2605 FERNBROOK LA Minneapolis, MN 55447 |
| Contact | Gregory J Mathison |
| Correspondent | Gregory J Mathison CLARUS MEDICAL SYSTEMS, INC. 2605 FERNBROOK LA Minneapolis, MN 55447 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent - Kit (SESK) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-06-16 |
| Decision Date | 1992-11-16 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B06711009051 | K922881 | 000 |
| B06711009000 | K922881 | 000 |
| B0671100010L0 | K922881 | 000 |
| B06711000100 | K922881 | 000 |
| B06711000020 | K922881 | 000 |