Device Classification Name |
electrosurgical, cutting & coagulation & accessories
|
510(k) Number |
K050364 |
Device Name |
MALIS 2000 BIPOLAR ELECTROSURGICAL SYSTEM |
Applicant |
VALLEY FORGE SCIENTIFIC CORP. |
136 GREEN TREE RD. |
P.O. BOX 1179 |
OAKS,
PA
19456
|
|
Applicant Contact |
JERRY L MALIS |
Correspondent |
VALLEY FORGE SCIENTIFIC CORP. |
136 GREEN TREE RD. |
P.O. BOX 1179 |
OAKS,
PA
19456
|
|
Correspondent Contact |
JERRY L MALIS |
Regulation Number | 878.4400
|
Classification Product Code |
|
Date Received | 02/14/2005 |
Decision Date | 03/09/2005 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|