Device Classification Name |
Tube, Gastro-Enterostomy
|
510(k) Number |
K073718 |
Device Name |
MEDLINE GASTROSTOMY TUBE |
Applicant |
MEDLINE INDUSTRIES, INC. |
ONE MEDLINE PLACE |
MUNDELEIN,
IL
60060
|
|
Applicant Contact |
MATT CLAUSEN |
Correspondent |
MEDLINE INDUSTRIES, INC. |
ONE MEDLINE PLACE |
MUNDELEIN,
IL
60060
|
|
Correspondent Contact |
MATT CLAUSEN |
Regulation Number | 876.5980
|
Classification Product Code |
|
Date Received | 12/31/2007 |
Decision Date | 03/19/2008 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Statement |
Statement
|
Type |
Abbreviated
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|