Device Classification Name |
Catheter, Urethrographic, Male
|
510(k) Number |
K013360 |
Device Name |
DFINER UROLOGICAL CATHETER |
Applicant |
NEOSEED TECHNOLOGY,LLC |
22 HILL ST. |
NEWBURYPORT,
MA
|
|
Applicant Contact |
MARK KIERAS |
Correspondent |
NEOSEED TECHNOLOGY,LLC |
22 HILL ST. |
NEWBURYPORT,
MA
|
|
Correspondent Contact |
MARK KIERAS |
Regulation Number | 876.5130
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 10/10/2001 |
Decision Date | 02/20/2002 |
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
|
|
|