510(k) K151575
- Device
- Dynarex Eye Cups
- Applicant
- DYNAREX CORPORATION
- 510(k) number
- K151575
- Product code
- LXQ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2015-09-01
- Date received
- 2015-06-11
- Regulation
- 510(k) Premarket Notification
- Classification name
- Cup, Eye
- Medical specialty
- 510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices
- Review panel
- Ophthalmic
- Device class
- U
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- JAMES HURLMAN
- Address
- 10 Glenshaw St. Orangeburg NY US 10962 10962
FDA Registration Numbers#
- 2183416
- 3008688054
- 3006542501
- 2431014
Source Documents#
Other 510(k) Records For Product Code LXQ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K140409 | FLENTS PLASTIC EYE WASH CUP | Apothecary Products, Inc. | 2014-07-09 |
| K051414 | EYE CUP, STERILE 1 AND NON STERILE | Tollot Pty.Ltd.(Aaxis Pacific) | 2005-06-16 |
| K971134 | VISTA EYESHOWER | John Branch | 1997-11-04 |
| K881369 | ADVANCE DIAGNOSTICS DISPOSABLE EYECUP | Advantage Diagnostics Corp. | 1988-05-13 |
Legacy Summary#
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FDA Review#
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