The following data is part of a premarket notification filed by Dynarex Corporation with the FDA for Dynarex Eye Cups.
| Device ID | K151575 |
| 510k Number | K151575 |
| Device Name: | Dynarex Eye Cups |
| Classification | Cup, Eye |
| Applicant | DYNAREX CORPORATION 10 GLENSHAW STREET Orangeburg, NY 10962 |
| Contact | James Hurlman |
| Correspondent | James Hurlman DYNAREX CORPORATION 10 GLENSHAW STREET Orangeburg, NY 10962 |
| 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 | 2015-06-11 |
| Decision Date | 2015-09-01 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00616784338002 | K151575 | 000 |