Device Classification Name |
Tube, Gastro-Enterostomy
|
510(k) Number |
K781333 |
Device Name |
CENTRAL CATHETER TRAY |
Applicant |
ARGON MEDICAL CORP. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Correspondent |
ARGON MEDICAL CORP. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Regulation Number | 876.5980
|
Classification Product Code |
|
Date Received | 08/02/1978 |
Decision Date | 10/24/1978 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|