Device Classification Name |
electrosurgical, cutting & coagulation & accessories
|
510(k) Number |
K002021 |
Device Name |
HEMOSTATIX THERMAL SCALPEL SYSTEM - #12 BLADE |
Applicant |
GYRUS ENT L.L.C. |
2925 APPLING RD. |
BARTLETT,
TN
38133
|
|
Applicant Contact |
ALICIA FARAGE |
Correspondent |
GYRUS ENT L.L.C. |
2925 APPLING RD. |
BARTLETT,
TN
38133
|
|
Correspondent Contact |
ALICIA FARAGE |
Regulation Number | 878.4400
|
Classification Product Code |
|
Date Received | 07/03/2000 |
Decision Date | 08/24/2000 |
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
|