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 |