Device Classification Name |
Electrosurgical, Cutting & Coagulation & Accessories
|
510(k) Number |
K201833 |
Device Name |
BiPad Hand Activated, Disposable Bipolar Electrocautery Cords |
Applicant |
BiPad Surgical, Inc. |
110 Ocean Blvd |
Point Lookout,
NY
11569
|
|
Applicant Contact |
Louis Cornacchia |
Correspondent |
Accelerated Device Approval Services |
6800 S.W. 40th Street, Ste. 403 |
Ludlum,
FL
33155
|
|
Correspondent Contact |
Rafael Aguila |
Regulation Number | 878.4400
|
Classification Product Code |
|
Date Received | 07/02/2020 |
Decision Date | 07/31/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|