Device Classification Name |
catheter, cholangiography
|
510(k) Number |
K924128 |
Device Name |
CHOLANGIOGRAPHY CATHETER |
Applicant |
APPLIED MEDICAL RESOURCES |
26051 MERIT CIRCLE |
BUILDING 104 |
LAGUNA HILLS,
CA
92653
|
|
Applicant Contact |
JO STEGWELL |
Correspondent |
APPLIED MEDICAL RESOURCES |
26051 MERIT CIRCLE |
BUILDING 104 |
LAGUNA HILLS,
CA
92653
|
|
Correspondent Contact |
JO STEGWELL |
Regulation Number | 878.4200
|
Classification Product Code |
|
Date Received | 08/17/1992 |
Decision Date | 02/10/1993 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|