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 |