The following data is part of a premarket notification filed by Menicon Co.,ltd. with the FDA for Menicon Saline Rinse Solution.
| Device ID | K151768 |
| 510k Number | K151768 |
| Device Name: | Menicon Saline Rinse Solution |
| Classification | Accessories, Soft Lens Products |
| Applicant | MENICON CO.,LTD. 21-19, AOI 3-CHOME, NAKA-KU Nagoya, JP 460-0006 |
| Contact | Tohru Kawaguchi |
| Correspondent | Ellen M Beucler FORESIGHT REGULATORY STRATEGIES, INC. 187 BALLARDVALE STREET, SUITE 180 Wilmington, MA 01887 |
| Product Code | LPN |
| CFR Regulation Number | 886.5928 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-06-30 |
| Decision Date | 2015-08-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00853253003201 | K151768 | 000 |
| 00853253003195 | K151768 | 000 |