The following data is part of a premarket notification filed by Aurolab with the FDA for Cornisol.
| Device ID | K221759 |
| 510k Number | K221759 |
| Device Name: | Cornisol |
| Classification | Media, Corneal Storage |
| Applicant | Aurolab No.1, Sivagangai Main Road Veerapanjan, Madurai, IN 625020 |
| Contact | Krishna Kumar |
| Correspondent | Sean Griffin Allied Regulatory Consulting 1540 Keller Parkway, Suite 108 #170 Keller, TX 76248 |
| Product Code | LYX |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-06-17 |
| Decision Date | 2022-10-05 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00803878044226 | K221759 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() CORNISOL 97562038 not registered Live/Pending |
Aurolab Trust 2022-08-24 |