Device Classification Name |
unit, electrosurgical and coagulation, with accessories
|
510(k) Number |
K963305 |
Device Name |
ALEXANDER BOX, BATTERY, RECHARGEABLE |
Applicant |
ALEXANDER MFG. CO. |
1511 S GARFIELD PL |
MASON CITY,
IA
50401
|
|
Applicant Contact |
STACEY HIPPEN |
Correspondent |
ALEXANDER MFG. CO. |
1511 S GARFIELD PL |
MASON CITY,
IA
50401
|
|
Correspondent Contact |
STACEY HIPPEN |
Regulation Number | 878.4400
|
Classification Product Code |
|
Date Received | 08/22/1996 |
Decision Date | 04/17/1997 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
Cardiovascular
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|