MENICON UNIQUE PH MULTI-PURPOSE SOLUTION
FDA 510(k) clearance K130805 · decided 2013-07-03
Clearance details
- K-number
- K130805
- Device name
- MENICON UNIQUE PH MULTI-PURPOSE SOLUTION
- Applicant
- Menicon Co, Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2013-03-25
- Decision date
- 2013-07-03
- Days to decision
- 100 days
- Clearance type
- Traditional
- Product code
- MRC
- Device class
- 2
- Regulation number
- 886.5918
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Wilmington, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.