The following data is part of a premarket notification filed by Berchtold Gmbh & Co. Kg with the FDA for Chromophare E 668.
| Device ID | K090378 |
| 510k Number | K090378 |
| Device Name: | CHROMOPHARE E 668 |
| Classification | Light, Surgical, Ceiling Mounted |
| Applicant | BERCHTOLD GMBH & CO. KG 1950 HANAHAN ROAD Charleston, SC 29406 |
| Contact | Heath Hines |
| Correspondent | Jeff D Rongero UNDERWRITERS LABORATORIES, INC. 12 LABORATORY DR. Research Triangle, NC 27709 |
| Product Code | FSY |
| CFR Regulation Number | 878.4580 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2009-02-17 |
| Decision Date | 2009-02-23 |
| Summary: | summary |