The following data is part of a premarket notification filed by Apothecary Products, Inc. with the FDA for Flents Plastic Eye Wash Cup.
Device ID | K140409 |
510k Number | K140409 |
Device Name: | FLENTS PLASTIC EYE WASH CUP |
Classification | Cup, Eye |
Applicant | APOTHECARY PRODUCTS, INC. 11750 12TH AVE. SOUTH Burnsville, MN 55337 |
Contact | James Jenkins |
Correspondent | James Jenkins APOTHECARY PRODUCTS, INC. 11750 12TH AVE. SOUTH Burnsville, MN 55337 |
Product Code | LXQ |
CFR Regulation Number | 510(k) Premarket Notification [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2014-02-18 |
Decision Date | 2014-07-09 |
Summary: | summary |