510(k) K905750
K905750 is an FDA 510(k) premarket notification submitted by Tamcenan Corp. for the device "LACRIMAL PLUG". The FDA issued a decision of Substantially Equivalent on March 14, 1991. The device falls under product code LZU (Plug, Punctum), a Class U device. Tamcenan Corp. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 14, 1991
- Date Received
- December 24, 1990
- 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