The following data is part of a premarket notification filed by Odyssey Medical, Inc. with the FDA for Lasik Eye Drape.
| Device ID | K042977 |
| 510k Number | K042977 |
| Device Name: | LASIK EYE DRAPE |
| Classification | Drape, Surgical |
| Applicant | ODYSSEY MEDICAL, INC. 5828 SHELBY OAKS DR. Memphis, TN 38134 |
| Contact | Ivan Harlan |
| Correspondent | Ivan Harlan ODYSSEY MEDICAL, INC. 5828 SHELBY OAKS DR. Memphis, TN 38134 |
| Product Code | KKX |
| CFR Regulation Number | 878.4370 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-10-28 |
| Decision Date | 2005-05-10 |
| Summary: | summary |