Device Classification Name |
Electrosurgical, Cutting & Coagulation & Accessories
|
510(k) Number |
K051420 |
Device Name |
HABIB 4X |
Applicant |
EMCISION, LTD. |
DU CANE ROAD |
LONDON,
GB
W12 0HS
|
|
Applicant Contact |
NAGY HABIB |
Correspondent |
UNDERWRITERS LABORATORIES, INC. |
333 PFINGSTEN RD. |
NORTHBROOK,
IL
60062
|
|
Correspondent Contact |
CHANTEL CARSON |
Regulation Number | 878.4400
|
Classification Product Code |
|
Date Received | 06/01/2005 |
Decision Date | 08/15/2005 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|