Device Classification Name |
light source, endoscope, xenon arc
|
510(k) Number |
K911492 |
Device Name |
ENDOSCOPIC LIGHT SOURCE |
Applicant |
UNITED STATES ENDOSCOPY GROUP, INC. |
7123 INDUSTRIAL PARK BLVD. |
MENTOR,
OH
44060
|
|
Applicant Contact |
DEAN SECREST |
Correspondent |
UNITED STATES ENDOSCOPY GROUP, INC. |
7123 INDUSTRIAL PARK BLVD. |
MENTOR,
OH
44060
|
|
Correspondent Contact |
DEAN SECREST |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 04/04/1991 |
Decision Date | 08/14/1991 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|