Device Classification Name |
Accessories, Pump, Infusion
|
510(k) Number |
K972089 |
Device Name |
ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER MS06224 |
Applicant |
ALEXANDER MFG. CO. |
1511 S GARFIELD PL |
MASON CITY,
IA
50401
|
|
Applicant Contact |
KEN HEIMENDINGER |
Correspondent |
ALEXANDER MFG. CO. |
1511 S GARFIELD PL |
MASON CITY,
IA
50401
|
|
Correspondent Contact |
KEN HEIMENDINGER |
Regulation Number | 880.5725 |
Classification Product Code |
|
Date Received | 06/04/1997 |
Decision Date | 07/03/1997 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|