Device Classification Name |
indicator, biological sterilization process |
|||
---|---|---|---|---|
510(k) Number | K122362 | |||
Device Name | SMART-WELL INCUBATOR | |||
Applicant |
|
|||
Applicant Contact | jole wilson | |||
Correspondent |
|
|||
Correspodent Contact | jole wilson | |||
Regulation Number | 880.2800 | |||
Classification Product Code |
|
|||
Date Received | 08/06/2012 | |||
Decision Date | 03/26/2013 | |||
Decision |
substantially equivalent (SESE) |
|||
Regulation Medical Specialty |
General Hospital |
|||
510k Review Panel |
General Hospital |
|||
statement |
statement |
|||
Type | Special | |||
Reviewed by Third Party | No | |||
Combination Product |
No |