Device Classification Name |
Tubes, Gastrointestinal (And Accessories)
|
510(k) Number |
K860285 |
Device Name |
XRO GASTRO-DUODENAL, DUAL FLOW TUBE, SALEM TYPE |
Applicant |
VYGON CORP. |
1 MADISON ST. |
EAST RUTHERFORD,
NJ
07073
|
|
Applicant Contact |
TONY J RIVERS |
Correspondent |
VYGON CORP. |
1 MADISON ST. |
EAST RUTHERFORD,
NJ
07073
|
|
Correspondent Contact |
TONY J RIVERS |
Regulation Number | 876.5980
|
Classification Product Code |
|
Date Received | 01/28/1986 |
Decision Date | 02/11/1986 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|