Device Classification Name |
tube, nasogastric
|
510(k) Number |
K905573 |
Device Name |
XEMEX ENTERAL NUTRITION CATHETER NASOGAS. TYPE A |
Applicant |
ZEON MEDICAL CORP. |
50 MAIN ST. |
WHITE PLAINS,
NY
10606
|
|
Applicant Contact |
BURNS, JR. |
Correspondent |
ZEON MEDICAL CORP. |
50 MAIN ST. |
WHITE PLAINS,
NY
10606
|
|
Correspondent Contact |
BURNS, JR. |
Regulation Number | 876.5980
|
Classification Product Code |
|
Date Received | 12/12/1990 |
Decision Date | 06/19/1991 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|