510(k) K090938
K090938 is an FDA 510(k) premarket notification submitted by Odyssey Medical, Inc. for the device "FLOW CONTROLLER". The FDA issued a decision of Substantially Equivalent on June 4, 2009. The device falls under product code LZU (Plug, Punctum), a Class U device. Odyssey Medical, Inc. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 4, 2009
- Date Received
- April 3, 2009
- 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