Device Classification Name |
Lamp, Surgical
|
510(k) Number |
K895715 |
Device Name |
HANAULUX(R) 2000 |
Applicant |
W.C. HERAEUS GMBH |
POSTFACH 1553 |
D-6450 HANAU 1 |
WEST GERMANY,
DE
|
|
Applicant Contact |
KLAAS OOSTLANDER |
Correspondent |
W.C. HERAEUS GMBH |
POSTFACH 1553 |
D-6450 HANAU 1 |
WEST GERMANY,
DE
|
|
Correspondent Contact |
KLAAS OOSTLANDER |
Regulation Number | 878.4580
|
Classification Product Code |
|
Date Received | 09/25/1989 |
Decision Date | 10/13/1989 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|