Device Classification Name |
electrosurgical, cutting & coagulation & accessories
|
510(k) Number |
K121977 |
Device Name |
PLASMAJET NEUTRAL PLASMA SURGERY SYSTEM |
Applicant |
PLASMA SURGICAL LIMITED |
127 MILTON PARK |
ABINGDON, OXFORDSHIRE,
GB
OX14 4SA
|
|
Applicant Contact |
PETER GIBSON |
Correspondent |
PLASMA SURGICAL LIMITED |
127 MILTON PARK |
ABINGDON, OXFORDSHIRE,
GB
OX14 4SA
|
|
Correspondent Contact |
PETER GIBSON |
Regulation Number | 878.4400
|
Classification Product Code |
|
Date Received | 07/05/2012 |
Decision Date | 11/20/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|