| Device Classification Name |
indicator, biological sterilization process
|
|---|
| 510(K) Number |
K121593 |
|---|
| Models |
1496V,
41482V
|
| Device Name |
3M ATTEST (TM) SUPER RADID READOUT STEAM CHALLENGE PACK 3M ATTEST(TM) SUPER RAPID 5 STEAM-PLUS CHALLENGE PACK |
|---|
| Applicant |
| 3M COMPANY |
| 3m center, bldg. 275-5w-06 |
|
st. paul,
MN
55144 1000
|
|
| Contact |
suzanne leung |
| Regulation Number | 880.2800
|
|---|
| Classification Product Code |
|
|---|
| Date Received | 05/31/2012 |
|---|
| Decision Date | 03/15/2013 |
|---|
| Decision |
substantially equivalent (SE) |
|---|
| Classification Advisory Committee |
General Hospital
|
|---|
| Review Advisory Committee |
General Hospital
|
|---|
| Type |
Traditional
|
|---|
| Reviewed by Third Party |
No
|
|---|
| Expedited Review |
No
|
|---|
| Combination Product |
No
|
|---|
|
|
