Device Classification Name |
motor, surgical instrument, ac-powered
|
510(k) Number |
K925360 |
Device Name |
ES-100 POWER SYSTEM, ES-100 SERIES |
Applicant |
ELEKTA INSTRUMENTS, INC. |
1926 NORTHLAKE PKWY. |
TUCKER,
GA
30084
|
|
Applicant Contact |
MARC BUNTAINE |
Correspondent |
ELEKTA INSTRUMENTS, INC. |
1926 NORTHLAKE PKWY. |
TUCKER,
GA
30084
|
|
Correspondent Contact |
MARC BUNTAINE |
Regulation Number | 878.4820
|
Classification Product Code |
|
Date Received | 10/22/1992 |
Decision Date | 09/07/1993 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|