The following data is part of a premarket notification filed by Haag-streit Holding Ag with the FDA for Optical Low Coherence Reflectometry (olcr) Pachymeter.
| Device ID | K030393 |
| 510k Number | K030393 |
| Device Name: | OPTICAL LOW COHERENCE REFLECTOMETRY (OLCR) PACHYMETER |
| Classification | Device, Analysis, Anterior Segment |
| Applicant | HAAG-STREIT HOLDING AG 7361 CALHOUN PLACE, SUITE 500 Rockville, MD 20855 -2465 |
| Contact | Eduardo March |
| Correspondent | Eduardo March HAAG-STREIT HOLDING AG 7361 CALHOUN PLACE, SUITE 500 Rockville, MD 20855 -2465 |
| Product Code | MXK |
| CFR Regulation Number | 886.1850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-02-05 |
| Decision Date | 2003-09-25 |
| Summary: | summary |