The following data is part of a premarket notification filed by Maca Plastics, Inc. with the FDA for Contact Lens Case.
| Device ID | K140488 |
| 510k Number | K140488 |
| Device Name: | CONTACT LENS CASE |
| Classification | Case, Contact Lens |
| Applicant | MACA PLASTICS, INC. 3455 CROSS ROAD Winchester, OH 45697 |
| Contact | Corrina Culbertson |
| Correspondent | Corrina Culbertson MACA PLASTICS, INC. 3455 CROSS ROAD Winchester, OH 45697 |
| Product Code | LRX |
| CFR Regulation Number | 886.5928 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-02-27 |
| Decision Date | 2014-09-10 |
| Summary: | summary |