Device Classification Name |
stents, drains and dilators for the biliary ducts
|
510(k) Number |
K983154 |
Device Name |
CYSTIC DUCT BALLOON DILATING CATHETER |
Applicant |
APPLIED MEDICAL RESOURCES |
26051 MERIT CIRCLE |
BUILDING 104 |
LAGUNA HILLS,
CA
92653
|
|
Applicant Contact |
HOWARD V ROWE |
Correspondent |
APPLIED MEDICAL RESOURCES |
26051 MERIT CIRCLE |
BUILDING 104 |
LAGUNA HILLS,
CA
92653
|
|
Correspondent Contact |
HOWARD V ROWE |
Regulation Number | 876.5010
|
Classification Product Code |
|
Date Received | 09/09/1998 |
Decision Date | 05/05/1999 |
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
|
|
|