Device Classification Name |
Electrosurgical, Cutting & Coagulation & Accessories
|
510(k) Number |
K060232 |
Device Name |
TROKAMED GMBH ELECTROSURGICAL INSTRUMENTS & ACCESSORIES |
Applicant |
TROKAMED GMBH |
KLEINE BREITE 17 |
GEISINGEN,
DE
78187
|
|
Applicant Contact |
KARLHEINZ TRONDLE |
Correspondent |
TROKAMED GMBH |
KLEINE BREITE 17 |
GEISINGEN,
DE
78187
|
|
Correspondent Contact |
KARLHEINZ TRONDLE |
Regulation Number | 878.4400
|
Classification Product Code |
|
Date Received | 01/30/2006 |
Decision Date | 07/12/2006 |
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
|