Device Classification Name |
electrode, electrosurgical
|
510(k) Number |
K874719 |
Device Name |
STRATUM ESU |
Applicant |
ALTERNATIVE DESIGN SYSTEMS, INC. |
419 HACKENSACK AVE. |
CARLSTADT,
NJ
07072
|
|
Applicant Contact |
ORLANDO, III |
Correspondent |
ALTERNATIVE DESIGN SYSTEMS, INC. |
419 HACKENSACK AVE. |
CARLSTADT,
NJ
07072
|
|
Correspondent Contact |
ORLANDO, III |
Regulation Number | 878.4400
|
Classification Product Code |
|
Date Received | 11/17/1987 |
Decision Date | 02/16/1988 |
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
|
|
|