Device Classification Name |
catheter, cannula and tubing, vascular, cardiopulmonary bypass
|
510(k) Number |
K992932 |
Device Name |
CIPA (ADULTS) CIPI (INFANTS) |
Applicant |
DMC MEDICAL LTD. |
511 CATALINA RD. |
FULLERTON,
CA
92835
|
|
Applicant Contact |
CHARMAINE HENDERSON |
Correspondent |
DMC MEDICAL LTD. |
511 CATALINA RD. |
FULLERTON,
CA
92835
|
|
Correspondent Contact |
CHARMAINE HENDERSON |
Regulation Number | 870.4210
|
Classification Product Code |
|
Date Received | 08/31/1999 |
Decision Date | 06/07/2000 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|