Device Classification Name |
Catheter, Urethral
|
510(k) Number |
K961361 |
Device Name |
ASTA-CATH |
Applicant |
A+ PRODUCTS |
16 ALDEN PL. |
WEST NEWTON,
MA
02465
|
|
Applicant Contact |
LINDA R ASTA |
Correspondent |
A+ PRODUCTS |
16 ALDEN PL. |
WEST NEWTON,
MA
02465
|
|
Correspondent Contact |
LINDA R ASTA |
Regulation Number | 876.5130
|
Classification Product Code |
|
Date Received | 04/09/1996 |
Decision Date | 10/31/1996 |
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
|
|
|