510(k) K001737

OPAQUE HERRICK PLUG, 0.3MM; 0.5MM; O.7MM by Lacrimedics, Inc. — Product Code LZU

K001737 is an FDA 510(k) premarket notification submitted by Lacrimedics, Inc. for the device "OPAQUE HERRICK PLUG, 0.3MM; 0.5MM; O.7MM". The FDA issued a decision of Substantially Equivalent on June 19, 2000. 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
June 19, 2000
Date Received
June 7, 2000
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