Device Classification Name |
insufflator, automatic carbon-dioxide for endoscope
|
510(k) Number |
K053008 |
Device Name |
E-Z-EM ENDOSCOPIC CO2 REGULATOR |
Applicant |
E-Z-EM, INC. |
750 SUMMA AVE. |
WESTBURY,
NY
11590
|
|
Applicant Contact |
ROBERT WILLIAMS |
Correspondent |
E-Z-EM, INC. |
750 SUMMA AVE. |
WESTBURY,
NY
11590
|
|
Correspondent Contact |
ROBERT WILLIAMS |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 10/26/2005 |
Decision Date | 12/27/2005 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Statement |
Statement
|
Type |
Abbreviated
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|