Device Classification Name |
Electrosurgical, Cutting & Coagulation & Accessories
|
510(k) Number |
K143306 |
FOIA Releasable 510(k) |
K143306
|
Device Name |
ERBE WaterJet Model ERBEJET® 2 System with HybridAPC Probe |
Applicant |
ERBE USA, INC. |
2225 NORTHWEST PARKWAY |
MARIETTA,
GA
30067
|
|
Applicant Contact |
JOHN TARTAL |
Correspondent |
ERBE USA, INC. |
2225 NORTHWEST PARKWAY |
MARIETTA,
GA
30067
|
|
Correspondent Contact |
JOHN TARTAL |
Regulation Number | 878.4400
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 11/18/2014 |
Decision Date | 10/27/2015 |
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
|