K013613 is an FDA 510(k) clearance for the SOFT PLUG ABSORBABLE PLUG-SA. This device is classified as a Plug, Punctum.
Submitted by Oasis Medical, Inc. (Glendora, US). The FDA issued a Cleared decision on June 27, 2002, 234 days after receiving the submission on November 5, 2001.
This device falls under the Ophthalmic FDA review panel.
| 510(k) Number | K013613 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 05, 2001 |
| Decision Date | June 27, 2002 |
| Days to Decision | 234 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
| Product Code | LZU - Plug, Punctum |
| Device Class | - |