Device Classification Name |
indicator, physical/chemical sterilization process
|
510(k) Number |
K200272 |
Device Name |
Terragene Chemdye |
Applicant |
Terragene SA |
Ruta Nacional No. 9, Km 280, Parque Industrial Micropi |
Alvear,
AR
2130
|
|
Applicant Contact |
Maria Victoria Rocha |
Correspondent |
Licensale Inc |
3422 Leonard Ln |
New Smyrna Beach,
FL
32168
|
|
Correspondent Contact |
Raymond Kelly |
Regulation Number | 880.2800
|
Classification Product Code |
|
Date Received | 02/04/2020 |
Decision Date | 06/30/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|