The following data is part of a premarket notification filed by Berchtold Holding Gmbh with the FDA for Chromophare D 530 Ldr Surgical Light.
| Device ID | K990656 |
| 510k Number | K990656 |
| Device Name: | CHROMOPHARE D 530 LDR SURGICAL LIGHT |
| Classification | Light, Surgical, Ceiling Mounted |
| Applicant | BERCHTOLD HOLDING GMBH LUDWIGSTALER STR. 25 Tuttlingen, DE D-78532 |
| Contact | Wolfram K Hill |
| Correspondent | Wolfram K Hill BERCHTOLD HOLDING GMBH LUDWIGSTALER STR. 25 Tuttlingen, DE D-78532 |
| Product Code | FSY |
| CFR Regulation Number | 878.4580 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-03-01 |
| Decision Date | 1999-07-20 |
| Summary: | summary |