Device Classification Name |
catheter, cannula and tubing, vascular, cardiopulmonary bypass
|
510(k) Number |
K981601 |
Device Name |
CALIFORNIA MEDICAL LABORATORIES INC. MALLEABLE VENT CATHETER |
Applicant |
CALIFORNIA MEDICAL LABORATORIES, INC. |
2681 KELVIN AVE. |
IRVINE,
CA
92614
|
|
Applicant Contact |
MEHMET BICAKCI |
Correspondent |
CALIFORNIA MEDICAL LABORATORIES, INC. |
2681 KELVIN AVE. |
IRVINE,
CA
92614
|
|
Correspondent Contact |
MEHMET BICAKCI |
Regulation Number | 870.4210
|
Classification Product Code |
|
Date Received | 05/04/1998 |
Decision Date | 07/28/1998 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|