Device Classification Name |
Apparatus, Electrosurgical
|
510(k) Number |
K000079 |
Device Name |
NIKOPAD ELECTROSURGICAL GROUNDING PAD, MODEL 4777M |
Applicant |
NIKOMED U.S.A., INC. |
P.O. BOX 560 |
STILLWATER,
MN
55082
|
|
Applicant Contact |
ELAINE DUNCAN |
Correspondent |
NIKOMED U.S.A., INC. |
P.O. BOX 560 |
STILLWATER,
MN
55082
|
|
Correspondent Contact |
ELAINE DUNCAN |
Regulation Number | 878.4400
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 01/11/2000 |
Decision Date | 02/04/2000 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|