Device Classification Name |
electrosurgical, cutting & coagulation & accessories
|
510(k) Number |
K051168 |
Device Name |
BARRX HALO 360 SYSTEM, MODEL 1100C-115A |
Applicant |
BARRX MEDICAL, INCORPORATED |
555 THIRTEENTH STREET, NW |
WASHINGTON,
DC
20004
|
|
Applicant Contact |
JONATHAN S KAHAN |
Correspondent |
BARRX MEDICAL, INCORPORATED |
555 THIRTEENTH STREET, NW |
WASHINGTON,
DC
20004
|
|
Correspondent Contact |
JONATHAN S KAHAN |
Regulation Number | 878.4400
|
Classification Product Code |
|
Date Received | 05/05/2005 |
Decision Date | 06/29/2005 |
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
|
|
|