Device Classification Name |
cystoscope and accessories, flexible/rigid
|
510(k) Number |
K093725 |
Device Name |
CYSTOSCOPE, MODELS CE0004-C, CE006-C, CE3004-C, CE3027-C, CE7004-C, CE1204-C, CE1227-C |
Applicant |
CANADA ENDOSCOPE CORPORATION |
1590 OAKBURN ST |
PICKERING, ON,
CA
L1V 6M9
|
|
Applicant Contact |
ROGER LECLERC |
Correspondent |
CANADA ENDOSCOPE CORPORATION |
1590 OAKBURN ST |
PICKERING, ON,
CA
L1V 6M9
|
|
Correspondent Contact |
ROGER LECLERC |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 12/03/2009 |
Decision Date | 08/30/2010 |
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
|
|
|