Device Classification Name |
endoscopic access overtube, gastroenterology-urology
|
510(k) Number |
K123013 |
Device Name |
ENDOSCOPIC INTRODUCER |
Applicant |
NOVADAQ TECHNOLOGIES, INC. |
13155 DELF PLACE, UNIT 250 |
RICHMOND, BRITISH COLUMBIA,
CA
V6V 2A2
|
|
Applicant Contact |
TIM VERSPAGEN |
Correspondent |
NOVADAQ TECHNOLOGIES, INC. |
13155 DELF PLACE, UNIT 250 |
RICHMOND, BRITISH COLUMBIA,
CA
V6V 2A2
|
|
Correspondent Contact |
TIM VERSPAGEN |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 09/28/2012 |
Decision Date | 03/22/2013 |
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
|
|
|