Device Classification Name |
Sterilizer, Ethylene-Oxide Gas
|
510(k) Number |
K142034 |
Device Name |
3M STERI-VAC STERILIZER/AERATOR |
Applicant |
3M COMPANY |
3M CENTER, BUILDING 275-SW-06 |
ST. PAUL,
MN
55144
|
|
Applicant Contact |
MATT MORTENSEN |
Correspondent |
3M COMPANY |
3M CENTER, BUILDING 275-SW-06 |
ST. PAUL,
MN
55144
|
|
Correspondent Contact |
MATT MORTENSEN |
Regulation Number | 880.6860
|
Classification Product Code |
|
Date Received | 07/28/2014 |
Decision Date | 01/08/2015 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Summary |
Summary
|
Type |
Abbreviated
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|