Device Classification Name |
Indicator, Biological Sterilization Process
|
510(k) Number |
K121484 |
Device Name |
3M ATTEST(TM) SUPER RAPID READOUT BIOLOGICAL INDICATOR, 3M ATTEST(TM) AUTO-READER |
Applicant |
3M COMPANY |
3M CENTER, BLDG. 275-5W-06 |
ST. PAUL,
MN
55144 -1000
|
|
Applicant Contact |
SUZANNE LEUNG |
Correspondent |
3M COMPANY |
3M CENTER, BLDG. 275-5W-06 |
ST. PAUL,
MN
55144 -1000
|
|
Correspondent Contact |
SUZANNE LEUNG |
Regulation Number | 880.2800
|
Classification Product Code |
|
Date Received | 05/18/2012 |
Decision Date | 10/19/2012 |
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
|
|
|