510(k) K161819
K161819 is an FDA 510(k) premarket notification submitted by Bausch & Lomb, Incorporated for the device "NNR06 Multi-Purpose Solution". The FDA issued a decision of Substantially Equivalent on November 25, 2016. The device falls under product code LPN (Accessories, Soft Lens Products), a Class II device regulated under 21 CFR 886.5928. Bausch & Lomb, Incorporated has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 25, 2016
- Date Received
- July 1, 2016
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Accessories, Soft Lens Products
- Device Class
- Class II
- Regulation Number
- 886.5928
- Review Panel
- OP
- Submission Type