Device Classification Name |
Sterilizer, Ethylene-Oxide Gas
|
510(k) Number |
K192978 |
Device Name |
EOGas 4 Ethylene Oxide Gas Sterilizer |
Applicant |
Andersen Sterilizers, Inc. |
3154 Caroline Drive |
Haw River,
NC
27258
|
|
Applicant Contact |
William K. Andersen |
Correspondent |
Andersen Sterilizers, Inc. |
3154 Caroline Drive |
Haw River,
NC
27258
|
|
Correspondent Contact |
William K. Andersen |
Regulation Number | 880.6860
|
Classification Product Code |
|
Date Received | 10/24/2019 |
Decision Date | 11/12/2020 |
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
|
|
|