Device Classification Name |
Insufflator, Automatic Carbon-Dioxide For Endoscope
|
510(k) Number |
K132192 |
Device Name |
BRACCO DIAGNOSTICS INC. PROTOCO, L TOUCH COLON INSUFFLATOR |
Applicant |
BRACCO DIAGNOSTIC, INC. |
259 PROSPECT PLAINS ROAD |
BUILDING H |
MONROE TOWNSHIP,
NJ
08831
|
|
Applicant Contact |
TRACEY ALEXANDER |
Correspondent |
BRACCO DIAGNOSTIC, INC. |
259 PROSPECT PLAINS ROAD |
BUILDING H |
MONROE TOWNSHIP,
NJ
08831
|
|
Correspondent Contact |
TRACEY ALEXANDER |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 07/15/2013 |
Decision Date | 02/14/2014 |
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
|
|
|