The following data is part of a premarket notification filed by Paragon Bioteck, Inc. with the FDA for Comfortear Lacrisolve Absorbable Punctum Plug, Lacrisolve Absorbable Punctum Plug, Comfortear Lacrisolve Punctum Plug,.
| Device ID | K140711 |
| 510k Number | K140711 |
| Device Name: | COMFORTEAR LACRISOLVE ABSORBABLE PUNCTUM PLUG, LACRISOLVE ABSORBABLE PUNCTUM PLUG, COMFORTEAR LACRISOLVE PUNCTUM PLUG, |
| Classification | Plug, Punctum |
| Applicant | PARAGON BIOTECK, INC. 4640 SW MACADAM, STE 80 Portland, OR 97239 |
| Contact | Lauren M-c Bluett |
| Correspondent | Lauren M-c Bluett PARAGON BIOTECK, INC. 4640 SW MACADAM, STE 80 Portland, OR 97239 |
| Product Code | LZU |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-03-21 |
| Decision Date | 2014-06-20 |
| Summary: | summary |