Device Classification Name |
Light Source, Fiberoptic, Routine
|
510(k) Number |
K121724 |
Device Name |
ENDOLIGHT LED 1.1 ENDOLIGHTLED 1.2 |
Applicant |
RICHARD WOLF MEDICAL INSTRUMENTS CORP. |
353 CORPORATE WOODS PKWY. |
VERNON HILLS,
IL
60061
|
|
Applicant Contact |
RON HASELHORST |
Correspondent |
RICHARD WOLF MEDICAL INSTRUMENTS CORP. |
353 CORPORATE WOODS PKWY. |
VERNON HILLS,
IL
60061
|
|
Correspondent Contact |
RON HASELHORST |
Regulation Number | 876.1500
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 06/12/2012 |
Decision Date | 09/20/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|