Device Classification Name |
Electrosurgical, Cutting & Coagulation & Accessories
|
510(k) Number |
K200841 |
Device Name |
Harmonic 1100 Shears, 20cm length, Harmonic 1100 36cm length, Generator G11 |
Applicant |
Ethicon Endo-Surgery, Llc |
475 Calle C |
Guaynabo,
PR
00969
|
|
Applicant Contact |
Nathan Anderson |
Correspondent |
Ethicon Endo-Surgery, Inc |
4545 Creek Rd |
Cincinnati,
OH
45242
|
|
Correspondent Contact |
Brian Godwin |
Regulation Number | 878.4400
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 03/31/2020 |
Decision Date | 05/11/2020 |
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
|
|
|