Device Classification Name |
Electrosurgical, Cutting & Coagulation & Accessories
|
510(k) Number |
K990723 |
Device Name |
DYONICS VARICOSE VEIN ABLATION BLADE |
Applicant |
SMITH & NEPHEW, INC. |
160 DASCOMB RD. |
ANDOVER,
MA
01810
|
|
Applicant Contact |
DEBORAH CONNORS |
Correspondent |
SMITH & NEPHEW, INC. |
160 DASCOMB RD. |
ANDOVER,
MA
01810
|
|
Correspondent Contact |
DEBORAH CONNORS |
Regulation Number | 878.4400
|
Classification Product Code |
|
Date Received | 03/05/1999 |
Decision Date | 10/05/1999 |
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
|
Recalls |
CDRH Recalls
|