Device Classification Name |
Apparatus, Autotransfusion
|
510(k) Number |
K892819 |
Device Name |
AUTOTRANSFUSION DEVICE |
Applicant |
IMPRA, INC. |
1625 WEST 3RD ST. |
P.O. BOX 1740 |
TEMPE,
AZ
85281
|
|
Applicant Contact |
PHILIP GOFORTH |
Correspondent |
IMPRA, INC. |
1625 WEST 3RD ST. |
P.O. BOX 1740 |
TEMPE,
AZ
85281
|
|
Correspondent Contact |
PHILIP GOFORTH |
Regulation Number | 868.5830
|
Classification Product Code |
|
Date Received | 04/17/1989 |
Decision Date | 05/22/1989 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|