Device Classification Name |
Colonoscope And Accessories, Flexible/Rigid
|
510(k) Number |
K102616 |
Device Name |
NAVIAID BALLOON GUIDED COLONOSCOPY (BGC) DEVICE |
Applicant |
SMART MEDICAL SYSTEMS, LTD. |
10 HAYETSIRA STREET |
RAANANA,
IL
43663
|
|
Applicant Contact |
ADVA YOSELZON |
Correspondent |
SMART MEDICAL SYSTEMS, LTD. |
10 HAYETSIRA STREET |
RAANANA,
IL
43663
|
|
Correspondent Contact |
ADVA YOSELZON |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 09/10/2010 |
Decision Date | 12/30/2010 |
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
|
|
|