Device Classification Name |
Catheter, Straight
|
510(k) Number |
K103086 |
Device Name |
DYNAREX INTERMITTENT CATHETERS, MALE, FEMALE, PEDIATRIC |
Applicant |
DYNAREX CORPORATION |
10 GLENSHAW ST. |
ORANGEBURG,
NY
10962
|
|
Applicant Contact |
DANIEL CONSAGA |
Correspondent |
DYNAREX CORPORATION |
10 GLENSHAW ST. |
ORANGEBURG,
NY
10962
|
|
Correspondent Contact |
DANIEL CONSAGA |
Regulation Number | 876.5130
|
Classification Product Code |
|
Date Received | 10/19/2010 |
Decision Date | 06/07/2011 |
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
|
|
|