Device Classification Name |
Catheter, Urethral
|
510(k) Number |
K012374 |
Device Name |
MODIFICATION TO: LOFRIC PLUS SINGLE USE URINARY CATHETER |
Applicant |
ASTRA TECH, INC. |
96 WEST MAIN ST. |
NORTHBOROUGH,
MA
01532
|
|
Applicant Contact |
BRUCE R MANNING |
Correspondent |
ASTRA TECH, INC. |
96 WEST MAIN ST. |
NORTHBOROUGH,
MA
01532
|
|
Correspondent Contact |
BRUCE R MANNING |
Regulation Number | 876.5130 |
Classification Product Code |
|
Date Received | 07/26/2001 |
Decision Date | 08/23/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|