510(k) K970631
K970631 is an FDA 510(k) premarket notification submitted by Odyssey Medical, Inc. for the device "PUNCTUAL OCCLUDER". The FDA issued a decision of Substantially Equivalent on April 23, 1997. 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
- April 23, 1997
- Date Received
- February 19, 1997
- 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