Device Classification Name |
console, heart-lung machine, cardiopulmonary bypass
|
510(k) Number |
K863541 |
Device Name |
STOCKERT-SHILEY CAPS HLM INTERFACE |
Applicant |
SHILEY, INC. |
17600 GILLETTE AVE. |
P.O. BOX 19503 |
IRVINE,
CA
92714
|
|
Applicant Contact |
MORTON BARAK |
Correspondent |
SHILEY, INC. |
17600 GILLETTE AVE. |
P.O. BOX 19503 |
IRVINE,
CA
92714
|
|
Correspondent Contact |
MORTON BARAK |
Regulation Number | 870.4220
|
Classification Product Code |
|
Date Received | 09/11/1986 |
Decision Date | 11/18/1986 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|