The following data is part of a premarket notification filed by Heraeus Instruments Gmbh with the FDA for Hanaulux 2005 Surgical Light.
| Device ID | K932451 |
| 510k Number | K932451 |
| Device Name: | HANAULUX 2005 SURGICAL LIGHT |
| Classification | Lamp, Surgical |
| Applicant | HERAEUS INSTRUMENTS GMBH HERAEUS STRASSE 12-14 Hanau, DE 63450 |
| Contact | Markus Steckhan |
| Correspondent | Markus Steckhan HERAEUS INSTRUMENTS GMBH HERAEUS STRASSE 12-14 Hanau, DE 63450 |
| Product Code | FTD |
| CFR Regulation Number | 878.4580 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-05-20 |
| Decision Date | 1993-11-12 |