Device Classification Name |
Electrosurgical, Cutting & Coagulation & Accessories
|
510(k) Number |
K010661 |
Device Name |
MODIFICATION TO TISSUELINK BIPOLAR FORCEPS |
Applicant |
TISSUELINK MEDICAL, INC. |
ONE WASHINGTON CENTER |
SUITE 400 |
DOVER,
NH
|
|
Applicant Contact |
ROBERTA THOMPSON |
Correspondent |
TISSUELINK MEDICAL, INC. |
ONE WASHINGTON CENTER |
SUITE 400 |
DOVER,
NH
|
|
Correspondent Contact |
ROBERTA THOMPSON |
Regulation Number | 878.4400
|
Classification Product Code |
|
Date Received | 03/01/2001 |
Decision Date | 05/03/2001 |
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
|