510(k) K150288
K150288 is an FDA 510(k) premarket notification submitted by Riverpoint Medical for the device "PDO Absorbable Punctum Plug". The FDA issued a decision of Substantially Equivalent on August 28, 2015. The device falls under product code LZU (Plug, Punctum), a Class U device. Riverpoint Medical has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 28, 2015
- Date Received
- February 5, 2015
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Plug, Punctum
- Device Class
- Class U
- Regulation Number
- Review Panel
- OP
- Submission Type