The following data is part of a premarket notification filed by W.c. Heraeus Gmbh with the FDA for Hanaulux(r) 2000.
| Device ID | K895715 |
| 510k Number | K895715 |
| Device Name: | HANAULUX(R) 2000 |
| Classification | Lamp, Surgical |
| Applicant | W.C. HERAEUS GMBH POSTFACH 1553 D-6450 HANAU 1 West Germany, DE |
| Contact | Klaas Oostlander |
| Correspondent | Klaas Oostlander W.C. HERAEUS GMBH POSTFACH 1553 D-6450 HANAU 1 West Germany, DE |
| Product Code | FTD |
| CFR Regulation Number | 878.4580 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-09-25 |
| Decision Date | 1989-10-13 |