Device Classification Name |
Tubes, Gastrointestinal (And Accessories)
|
510(k) Number |
K981323 |
Device Name |
COMPAT MINI-G REPLACEMENT GASTROSTOMY TUBE |
Applicant |
NOVARTIS NUTRITION CORP. |
5320 WEST 23RD ST. |
PO BOX 370 |
MINNEAPOLIS,
MN
55440
|
|
Applicant Contact |
ROBERT J LANG |
Correspondent |
NOVARTIS NUTRITION CORP. |
5320 WEST 23RD ST. |
PO BOX 370 |
MINNEAPOLIS,
MN
55440
|
|
Correspondent Contact |
ROBERT J LANG |
Regulation Number | 876.5980
|
Classification Product Code |
|
Date Received | 04/13/1998 |
Decision Date | 10/09/1998 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|