Menicon Saline Rinse Solution— 510(k) K151768

Substantially Equivalent

Menicon Co, Ltd.

FDA 510(k) clearance K151768 for Menicon Saline Rinse Solution, Substantially Equivalent on 2015-08-28. Applicant: Menicon Co, Ltd..

Clearance details

Applicant
Menicon Co, Ltd.
Product code
Code LPN
Advisory panel
Ophthalmic
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Nagoya, JP
Download summary PDFView on FDA.gov ↗

Adverse events under product code LPN

product code LPN
Injury
333
Other
8
Total
341

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.