The following data is part of a premarket notification filed by Apothecary Products, Inc. with the FDA for Soft Grip Contact Lens Case, Deluxe Contact Lens Case, Econo-mate Contact Lens Case.
Device ID | K111856 |
510k Number | K111856 |
Device Name: | SOFT GRIP CONTACT LENS CASE, DELUXE CONTACT LENS CASE, ECONO-MATE CONTACT LENS CASE |
Classification | Case, Contact Lens |
Applicant | APOTHECARY PRODUCTS, INC. 11750 12TH AVE. SOUTH Burnsville, MN 55337 |
Contact | James Jenkins |
Correspondent | Bhavesh V Sheth INTERTEK TESTING SERVICES 2307 EAST AURORA ROAD UNIT B7 Twinsburg, OH 44087 |
Product Code | LRX |
CFR Regulation Number | 886.5928 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | Yes |
Combination Product | No |
Date Received | 2011-06-29 |
Decision Date | 2011-07-14 |
Summary: | summary |