The following data is part of a premarket notification filed by Berchtold Holding Gmbh with the FDA for Chromophare E 778 And E 558.
| Device ID | K083066 |
| 510k Number | K083066 |
| Device Name: | CHROMOPHARE E 778 AND E 558 |
| Classification | Light, Surgical, Ceiling Mounted |
| Applicant | BERCHTOLD HOLDING GMBH LUDWIGSTALER STRABE 25 Tuttlingen, DE D-78532 |
| Contact | Silke Goral |
| 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 | 2008-10-15 |
| Decision Date | 2008-10-30 |
| Summary: | summary |