Menicon Saline Rinse Solution
FDA 510(k) clearance K151768 · decided 2015-08-28
Clearance details
- K-number
- K151768
- Device name
- Menicon Saline Rinse Solution
- Applicant
- Menicon Co, Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2015-06-30
- Decision date
- 2015-08-28
- Days to decision
- 59 days
- Clearance type
- Traditional
- Product code
- LPN
- Device class
- 2
- Regulation number
- 886.5928
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Nagoya, JP
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.