The following data is part of a premarket notification filed by Medtronic Xomed, Inc. with the FDA for Merocel Cornell Lid And Lash Guard, Merocel And Kerocel Ophthalmic Sponges.
| Device ID | K011191 |
| 510k Number | K011191 |
| Device Name: | MEROCEL CORNELL LID AND LASH GUARD, MEROCEL AND KEROCEL OPHTHALMIC SPONGES |
| Classification | Sponge, Ophthalmic |
| Applicant | MEDTRONIC XOMED, INC. 6743 SOUTHPOINT DR. NORTH Jacksonville, FL 32216 |
| Contact | Diana Taylor |
| Correspondent | Diana Taylor MEDTRONIC XOMED, INC. 6743 SOUTHPOINT DR. NORTH Jacksonville, FL 32216 |
| Product Code | HOZ |
| CFR Regulation Number | 886.4790 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-04-19 |
| Decision Date | 2001-06-26 |