Device Classification Name |
cystoscope and accessories, flexible/rigid
|
510(k) Number |
K093665 |
Device Name |
ENDO SMARTCAP |
Applicant |
BYRNE MEDICAL INC. |
3150 POLLOK DR |
CONROE,
TX
77303
|
|
Applicant Contact |
DON BYRNE |
Correspondent |
INTERTEK TESTING SERVICES |
2307 EAST AURORA ROAD |
UNIT B7 |
TWINSBURG,
OH
44087
|
|
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 11/25/2009 |
Decision Date | 12/15/2009 |
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
|
Recalls |
CDRH Recalls
|
|
|