Device Classification Name |
electrosurgical, cutting & coagulation & accessories
|
510(k) Number |
K000245 |
Device Name |
CSM STRETTA SYSTEM |
Applicant |
CONWAY STUART MEDICAL, INC. |
555 THIRTEENTH ST. N.W. |
WASHINGTON,
DC
20004 -1109
|
|
Applicant Contact |
JONATHAN S KAHAN |
Correspondent |
CONWAY STUART MEDICAL, INC. |
555 THIRTEENTH ST. N.W. |
WASHINGTON,
DC
20004 -1109
|
|
Correspondent Contact |
JONATHAN S KAHAN |
Regulation Number | 878.4400
|
Classification Product Code |
|
Date Received | 01/27/2000 |
Decision Date | 04/18/2000 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|