The following data is part of a premarket notification filed by Meditron, Gmbh with the FDA for Contact Lens Ophthalmodynamometer.
| Device ID | K052674 |
| 510k Number | K052674 |
| Device Name: | CONTACT LENS OPHTHALMODYNAMOMETER |
| Classification | Ophthalmodynamometer, Diagnostic Contact Lens, Polymethylmethacrylate (pmma) |
| Applicant | MEDITRON, GMBH 13605 W. 7TH AVE. Golden, CO 80401 -4604 |
| Contact | Robert N Clark |
| Correspondent | Robert N Clark MEDITRON, GMBH 13605 W. 7TH AVE. Golden, CO 80401 -4604 |
| Product Code | NYK |
| CFR Regulation Number | 886.1385 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-09-27 |
| Decision Date | 2006-05-24 |
| Summary: | summary |