Device Classification Name |
two or more sterilant sterilizer
|
510(k) Number |
K172191 |
Device Name |
STERIZONE VP4 Sterilizer |
Applicant |
TSO3 Inc |
2505 Avenue Dalton |
Quebec,
CA
G1P 3S5
|
|
Applicant Contact |
Alexandre Jokic |
Correspondent |
BioTechnology Transfer, LLC |
1016 Tobiano Lane |
Raleigh,
NC
27614
|
|
Correspondent Contact |
Cynthia G. Pritchard |
Regulation Number | 880.6860
|
Classification Product Code |
|
Date Received | 07/20/2017 |
Decision Date | 05/09/2018 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|