Device Classification Name |
pump, infusion
|
510(k) Number |
K913056 |
Device Name |
VOLUMETRIC INFUSION PUMP, MODIFICATION |
Applicant |
MCGAW, INC. |
2525 MCGAW AVE. |
P.O. BOX 19791 |
IRVINE,
CA
92713 -9791
|
|
Applicant Contact |
JOHN G D'ANGELO |
Correspondent |
MCGAW, INC. |
2525 MCGAW AVE. |
P.O. BOX 19791 |
IRVINE,
CA
92713 -9791
|
|
Correspondent Contact |
JOHN G D'ANGELO |
Regulation Number | 880.5725
|
Classification Product Code |
|
Date Received | 07/02/1991 |
Decision Date | 09/06/1991 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|