Device Classification Name |
Colonoscope And Accessories, Flexible/Rigid
|
510(k) Number |
K120289 |
Device Name |
PEERSCOPE SYSTEM |
Applicant |
PEERMEDICAL |
6 SIRENI |
HAIFA,
IL
32972
|
|
Applicant Contact |
DAN LAOR |
Correspondent |
PEERMEDICAL |
6 SIRENI |
HAIFA,
IL
32972
|
|
Correspondent Contact |
DAN LAOR |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 01/31/2012 |
Decision Date | 09/28/2012 |
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
|
|
|