Device Classification Name |
two or more sterilant sterilizer
|
510(k) Number |
K153689 |
Device Name |
STERIZONE Sterilizer |
Applicant |
TSO3 INC |
2505, AVENUE DALTON |
QUEBEC,
CA
G1P 3S5
|
|
Applicant Contact |
NATHALIE RACETTE |
Correspondent |
IM3, INC |
7720 NE HWY 99, SUITE D#110 |
VANCOUVER,
WA
98665
|
|
Correspondent Contact |
THOMAS RICHARDS |
Regulation Number | 880.6860
|
Classification Product Code |
|
Date Received | 12/23/2015 |
Decision Date | 06/30/2016 |
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
|
|
|