Device Classification Name |
Pump, Infusion
|
510(k) Number |
K920588 |
Device Name |
AVI MODEL 3000 INFUSION PUMP |
Applicant |
3M HEALTH CARE, LTD. |
3M CENTER, BLDG. 275-3E-08 |
P.O. BOX 33275 |
ST. PAUL,
MN
55133
|
|
Applicant Contact |
STANLEY J SUEDKAMP |
Correspondent |
3M HEALTH CARE, LTD. |
3M CENTER, BLDG. 275-3E-08 |
P.O. BOX 33275 |
ST. PAUL,
MN
55133
|
|
Correspondent Contact |
STANLEY J SUEDKAMP |
Regulation Number | 880.5725 |
Classification Product Code |
|
Date Received | 02/10/1992 |
Decision Date | 04/06/1992 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|