The following data is part of a premarket notification filed by Konan Medical, Inc. with the FDA for Konan Specular Microscope Xiv.
| Device ID | K120264 |
| 510k Number | K120264 |
| Device Name: | KONAN SPECULAR MICROSCOPE XIV |
| Classification | Microscope, Specular |
| Applicant | KONAN MEDICAL, INC. 2976 CALLE GAUCHO San Clemente, CA 92673 |
| Contact | David S Fernquist |
| Correspondent | David S Fernquist KONAN MEDICAL, INC. 2976 CALLE GAUCHO San Clemente, CA 92673 |
| Product Code | NQE |
| CFR Regulation Number | 886.1850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-01-30 |
| Decision Date | 2012-04-11 |
| Summary: | summary |