Device Classification Name |
Electrosurgical, Cutting & Coagulation & Accessories
|
510(k) Number |
K041810 |
Device Name |
SERFAS ENERGY SYSTEM |
Applicant |
Stryker Endoscopy |
5900 OPTICAL CT. |
SAN JOSE,
CA
95138
|
|
Applicant Contact |
CHRISTINE REISTETTER |
Correspondent |
TUV RHEINLAND OF NORTH AMERICA, INC. |
12 COMMERCE RD. |
NEWTON,
CT
06470
|
|
Correspondent Contact |
TAMAS BORSAI |
Regulation Number | 878.4400
|
Classification Product Code |
|
Date Received | 07/06/2004 |
Decision Date | 12/21/2004 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|