Device Classification Name |
catheter, straight
|
510(k) Number |
K122078 |
Device Name |
LOFRIC PRIMO, LOFRIC HYDRO-KIT |
Applicant |
ASTRA TECH, INC. |
11234 EL CAMINO REAL, STE 200 |
SAN DIEGO,
CA
92130
|
|
Applicant Contact |
Allison C Komiyama |
Correspondent |
ASTRA TECH, INC. |
11234 EL CAMINO REAL, STE 200 |
SAN DIEGO,
CA
92130
|
|
Correspondent Contact |
Allison C Komiyama |
Regulation Number | 876.5130
|
Classification Product Code |
|
Date Received | 07/16/2012 |
Decision Date | 10/31/2012 |
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
|
Recalls |
CDRH Recalls
|
|
|