Device Classification Name |
electrosurgical, cutting & coagulation & accessories
|
510(k) Number |
K012314 |
Device Name |
DYONICS ELECTROBLADE RESECTOR |
Applicant |
SMITH & NEPHEW, INC. |
160 DASCOMB RD. |
ANDOVER,
MA
01810
|
|
Applicant Contact |
TIM CRABTREE |
Correspondent |
SMITH & NEPHEW, INC. |
160 DASCOMB RD. |
ANDOVER,
MA
01810
|
|
Correspondent Contact |
TIM CRABTREE |
Regulation Number | 878.4400
|
Classification Product Code |
|
Date Received | 07/23/2001 |
Decision Date | 02/01/2002 |
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
|