Device Classification Name |
Catheter, Straight
|
510(k) Number |
K100302 |
Device Name |
MEDLINE PVC URETHRAL CATHETER |
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 | 876.5130
|
Classification Product Code |
|
Date Received | 02/03/2010 |
Decision Date | 07/02/2010 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|