Device Classification Name |
indicator, biological sterilization process
|
510(k) Number |
K192550 |
Device Name |
3MTM AttestTM Super Rapid Steam Biological Indicator 1592, 3MTM AttestTM Super Rapid Steam Challenge Pack, 3MTM AttestTM Auto- Readers 490 and 490H |
Applicant |
3M Company |
Bldg. 275-5W-06 |
St.Paul,
MN
55144
|
|
Applicant Contact |
Hilary B Hovde |
Correspondent |
3M Company |
Bldg. 275-5W-06 |
St.Paul,
MN
55144
|
|
Correspondent Contact |
Hilary B Hovde |
Regulation Number | 880.2800
|
Classification Product Code |
|
Date Received | 09/17/2019 |
Decision Date | 06/05/2020 |
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
|
|
|