Device Classification Name |
Electrosurgical, Cutting & Coagulation & Accessories
|
510(k) Number |
K073207 |
Device Name |
OLYMPUS ESG-100, MODEL WB991046; OLYMPUS AFU-100, MODEL WB950167 |
Applicant |
CELON AG MEDICAL INSTRUMENTS |
3500 CORPORATE PARKWAY |
CENTER VALLEY,
PA
18034
|
|
Applicant Contact |
LAURA STORMS-TYLER |
Correspondent |
CELON AG MEDICAL INSTRUMENTS |
3500 CORPORATE PARKWAY |
CENTER VALLEY,
PA
18034
|
|
Correspondent Contact |
LAURA STORMS-TYLER |
Regulation Number | 878.4400
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 11/13/2007 |
Decision Date | 05/08/2008 |
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
|