Device Classification Name |
Light Source, Fiberoptic, Routine
|
510(k) Number |
K032430 |
Device Name |
ACUEITY MEDICAL LIGHT SOURCE |
Applicant |
ACUEITY, INC. |
100 HAMILTON AVE., SUITE 140 |
PALO ALTO,
CA
94301
|
|
Applicant Contact |
NANCY LINCE |
Correspondent |
N.V. KEMA |
P.O. BOX 9035 |
6800 ET ARNHEM |
ARNHEM,
NL
|
|
Correspondent Contact |
P.N. RUYS |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 08/06/2003 |
Decision Date | 09/05/2003 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
|
|