The following data is part of a premarket notification filed by Berchtold Gmbh & Co. Kg with the FDA for Chromophare F 628 And F 528.
| Device ID | K120392 |
| 510k Number | K120392 |
| Device Name: | CHROMOPHARE F 628 AND F 528 |
| Classification | Light, Surgical, Ceiling Mounted |
| Applicant | BERCHTOLD GMBH & CO. KG LUDWIGSTALER STR. 25 Tuttlingen, DE D-78532 |
| Contact | Volker Hornscheidt |
| 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 | 2012-02-08 |
| Decision Date | 2012-02-16 |
| Summary: | summary |