The following data is part of a premarket notification filed by Menicon Co. Ltd. with the FDA for Menicon Unique Ph Multi-purpose Solution.
| Device ID | K130805 |
| 510k Number | K130805 |
| Device Name: | MENICON UNIQUE PH MULTI-PURPOSE SOLUTION |
| Classification | Products, Contact Lens Care, Rigid Gas Permeable |
| Applicant | MENICON CO. LTD. 187 BALLARDVALE STREET SUITE 180 Wilmington, MA 01887 |
| Contact | Ellen M Beucler |
| Correspondent | Ellen M Beucler MENICON CO. LTD. 187 BALLARDVALE STREET SUITE 180 Wilmington, MA 01887 |
| Product Code | MRC |
| CFR Regulation Number | 886.5918 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-03-25 |
| Decision Date | 2013-07-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00853253003065 | K130805 | 000 |
| 00853253003058 | K130805 | 000 |
| 00853253003003 | K130805 | 000 |