FDA 510(k) Applications for Medical Device:
Lens, Contact, Polymethylmethacrylate, Diagnostic
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K971853 | AMERICAN MEDICAL DEVICES, INC. |
1100 NORTHSIDE DR. | ATLANTA | GA | 30318 |
| K033950 | DUTCH OPHTHALMIC RESEARCH CENTER (D.O.R.C.) |
ONE LITTLE RIVER ROAD | KINGSTON | NH | 03848 |
| K030054 | FCI OPHTHALMICS, INC. |
344 ANNABELLE POINT RD. | CENTERVILLE | MA | 02632-2402 |
| K051103 | HAAG-STREIT USA, INC. |
7361 CALHOUN PLACE, SUITE 500 | ROCKVILLE | MD | 20855-2765 |
| K051630 | INSIGHT INSTRUMENTS, INC. |
5400 SOUTH BRYANT AVE. | SANFORD | FL | 32773 |
| K022413 | LUNEAU SA |
BP 252 | CHARTRES CEDEX | 28005 | |
| K012096 | OCULAR INSTRUMENTS, INC. |
2255 116TH AVE., N.E. | BELLEVUE | WA | 98004-3039 |
| K014170 | OCULAR INSTRUMENTS, INC. |
2255 116TH AVE., N.E. | BELLEVUE | WA | 98004-3039 |
| K173944 | Phakos |
62 Rue Kleber | Montreuil | 93100 | |
| K201909 | RxSight, Inc. |
100 Colombia | Aliso Viejo | CA | 92656 |
| K142715 | Sensor Medical Technology, LLC |
23175 224th Place SE | Maple Valley | WA | 98038 |
| K151961 | Volk Optical Inc. |
7893 Enterprise Drive | Mentor | OH | 44060 |
| K023221 | VOLK OPTICAL, INC. |
15825 SHADY GROVE RD. | ROCKVILLE | MD | 20850 |
| K050623 | VOLK OPTICAL, INC. |
15825 SHADY GROVE RD. | ROCKVILLE | MD | 20850 |
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