The following data is part of a premarket notification filed by Xodus Medical, Inc. with the FDA for Light Guard Light Handle And Light Handle Cover.
| Device ID | K053321 |
| 510k Number | K053321 |
| Device Name: | LIGHT GUARD LIGHT HANDLE AND LIGHT HANDLE COVER |
| Classification | Light, Surgical, Accessories |
| Applicant | XODUS MEDICAL, INC. 702 PROMINENCE DR. New Kensington, PA 15068 |
| Contact | Craig Kaforey |
| Correspondent | Craig Kaforey XODUS MEDICAL, INC. 702 PROMINENCE DR. New Kensington, PA 15068 |
| Product Code | FTA |
| CFR Regulation Number | 878.4580 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-11-30 |
| Decision Date | 2006-01-19 |
| Summary: | summary |