Device Classification Name |
monitor, spinal-fluid pressure, electrically powered
|
510(k) Number |
K915577 |
Device Name |
IMPRAFLO POSTOPERATIVE AUTOTRANSFUSION DEVICE |
Applicant |
IMPRA, INC. |
1625 WEST 3RD ST. |
P.O. BOX 1740 |
TEMPE,
AZ
85281
|
|
Applicant Contact |
RICH KAUFMAN |
Correspondent |
IMPRA, INC. |
1625 WEST 3RD ST. |
P.O. BOX 1740 |
TEMPE,
AZ
85281
|
|
Correspondent Contact |
RICH KAUFMAN |
Regulation Number | 880.2460
|
Classification Product Code |
|
Date Received | 12/13/1991 |
Decision Date | 03/11/1992 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|