Device Classification Name |
tubes, gastrointestinal (and accessories)
|
510(k) Number |
K831328 |
Device Name |
NEONATAL NASOGASTRIC FEEDING TUBE- |
Applicant |
CORPAK MEDSYSTEMS |
1001 Asbury Dr |
Buffalo Grove,
IL
60089
|
|
Applicant Contact |
Stephanie Wasielewski |
Correspondent |
CORPAK MEDSYSTEMS |
1001 Asbury Dr |
Buffalo Grove,
IL
60089
|
|
Correspondent Contact |
Stephanie Wasielewski |
Regulation Number | 876.5980
|
Classification Product Code |
|
Date Received | 04/25/1983 |
Decision Date | 07/19/1983 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|