Device Classification Name |
light source, endoscope, xenon arc
|
510(k) Number |
K992540 |
Device Name |
XENON LIGHT SOURCE PES 1 |
Applicant |
LASER OPTIK SYSTEME GMBH & CO. KG |
AM SAGEWERK 11,6500 MAINZ 23 |
AMTSGERICHT MAINZ HRB 4527 |
GERMANY,
DE
|
|
Applicant Contact |
R. HAPPERSBERGER |
Correspondent |
LASER OPTIK SYSTEME GMBH & CO. KG |
AM SAGEWERK 11,6500 MAINZ 23 |
AMTSGERICHT MAINZ HRB 4527 |
GERMANY,
DE
|
|
Correspondent Contact |
R. HAPPERSBERGER |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 07/29/1999 |
Decision Date | 09/14/1999 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|