Device Classification Name |
indicator, physical/chemical sterilization process
|
510(k) Number |
K220942 |
Device Name |
3M Attest Steam Chemical Integrators (1243A, 1243B, 1243RE, 1243RES) |
Applicant |
3M Company |
2510 Conway Avenue, Bldg. 275-5W-06 |
Saint Paul,
MN
55144 -1000
|
|
Applicant Contact |
Yumi Wackerfuss |
Correspondent |
3M Company |
2510 Conway Avenue, Bldg. 275-5W-06 |
Saint Paul,
MN
55144 -1000
|
|
Correspondent Contact |
Yumi Wackerfuss |
Regulation Number | 880.2800
|
Classification Product Code |
|
Date Received | 03/31/2022 |
Decision Date | 06/24/2022 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|