Device Classification Name |
Endoilluminator
|
510(k) Number |
K062895 |
Device Name |
XENON BRIGHTSTAR ILLUMINATION SYSTEM, MODEL 1266.XIII |
Applicant |
DUTCH OPHTHALMIC RESEARCH CENTER INTERNATIONAL BV |
ONE LITTLE RIVER RD. |
KINGSTON,
NH
03848
|
|
Applicant Contact |
F CARLETON |
Correspondent |
DUTCH OPHTHALMIC RESEARCH CENTER INTERNATIONAL BV |
ONE LITTLE RIVER RD. |
KINGSTON,
NH
03848
|
|
Correspondent Contact |
F CARLETON |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 09/27/2006 |
Decision Date | 10/13/2006 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Ophthalmic
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|