Device Classification Name |
Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed
|
510(k) Number |
K121855 |
Device Name |
RESPROCESSED SERFAS ENERGY PROBE |
Applicant |
STRYKER SUSTAINABILITY SOLUTIONS |
1810 WEST DRAKE DRIVE |
TEMPE,
AZ
85283
|
|
Applicant Contact |
ERIC VARTY |
Correspondent |
STRYKER SUSTAINABILITY SOLUTIONS |
1810 WEST DRAKE DRIVE |
TEMPE,
AZ
85283
|
|
Correspondent Contact |
ERIC VARTY |
Regulation Number | 878.4400
|
Classification Product Code |
|
Date Received | 06/25/2012 |
Decision Date | 08/16/2012 |
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
|