510(k) K021831
K021831 is an FDA 510(k) premarket notification submitted by Lacrimedics, Inc. for the device "OPAQUE HERRICK LACRIMAL PLUG, 0.3MM,0.5MM,0.7MM, MODELS HLP3-OPB,HLP50OPB,HLP7-OPB". The FDA issued a decision of Substantially Equivalent on July 1, 2002. The device falls under product code LZU (Plug, Punctum), a Class U device. Lacrimedics, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 1, 2002
- Date Received
- June 4, 2002
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Plug, Punctum
- Device Class
- Class U
- Regulation Number
- Review Panel
- OP
- Submission Type