510(k) K001768
K001768 is an FDA 510(k) premarket notification submitted by U.S. Iol, Inc. for the device "OCCU-FLO PUNCTUM PLUGS". The FDA issued a decision of Substantially Equivalent on Sep 19, 2000. The device falls under product code LZU (Plug, Punctum), a Class U device. U.S. Iol, Inc. has 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Sep 19, 2000
- Date Received
- Jun 12, 2000
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Plug, Punctum
- Device Class
- Class U
- Review Panel
- OP
- Submission Type
- 510(k)