Device Classification Name |
electrosurgical, cutting & coagulation & accessories
|
510(k) Number |
K183148 |
Device Name |
OKLand Patient Return Electrode Pad |
Applicant |
Auckland Medical Polymer(Tianjin) Co., Ltd. |
Building D5-2, XEDA International Industrial Park |
Tianjin,
CN
300385
|
|
Applicant Contact |
Bei Lei Gao |
Correspondent |
Auckland Medical Polymer(Tianjin) Co., Ltd. |
Building D5-2, XEDA International Industrial Park |
Tianjin,
CN
300385
|
|
Correspondent Contact |
Bei Lei Gao |
Regulation Number | 878.4400
|
Classification Product Code |
|
Date Received | 11/13/2018 |
Decision Date | 02/04/2020 |
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
|