Device Classification Name |
Apparatus, Autotransfusion
|
510(k) Number |
K881683 |
Device Name |
DIDECO-SHILEY AUTOTRANS BT 795/AA |
Applicant |
SHILEY, INC. |
17600 GILLETTE AVE. |
P.O. BOX 19503 |
IRVINE,
CA
92714
|
|
Applicant Contact |
GANZ POBUDA |
Correspondent |
SHILEY, INC. |
17600 GILLETTE AVE. |
P.O. BOX 19503 |
IRVINE,
CA
92714
|
|
Correspondent Contact |
GANZ POBUDA |
Regulation Number | 868.5830
|
Classification Product Code |
|
Date Received | 04/19/1988 |
Decision Date | 06/27/1988 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|