Device Classification Name |
gastroscope and accessories, flexible/rigid
|
510(k) Number |
K131422 |
Device Name |
PEERSCOPE SYSTEM |
Applicant |
ENDOCHOICE, INC. |
2 HATOCHEN ST., BUSINESS AND INDUSTRIAL PARK (NORTH) |
POB 3161 |
CAESAREA,
IL
38900
|
|
Applicant Contact |
TAMAR FUERST |
Correspondent |
ENDOCHOICE, INC. |
2 HATOCHEN ST., BUSINESS AND INDUSTRIAL PARK (NORTH) |
POB 3161 |
CAESAREA,
IL
38900
|
|
Correspondent Contact |
TAMAR FUERST |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 05/16/2013 |
Decision Date | 10/10/2013 |
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
|
|
|