The following data is part of a premarket notification filed by Xodus Medical, Inc. with the FDA for Xodus Medical Anti-fog Solution.
| Device ID | K063587 |
| 510k Number | K063587 |
| Device Name: | XODUS MEDICAL ANTI-FOG SOLUTION |
| Classification | Anti Fog Solution And Accessories, Endoscopy |
| Applicant | XODUS MEDICAL, INC. 702 PROMINENCE DR. New Kensington, PA 15068 |
| Contact | Brenda Niel |
| Correspondent | Brenda Niel XODUS MEDICAL, INC. 702 PROMINENCE DR. New Kensington, PA 15068 |
| Product Code | OCT |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-12-01 |
| Decision Date | 2007-01-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10326053102629 | K063587 | 000 |