Device Classification Name |
biological sterilization process indicator with recombinant-dna plasmid
|
De Novo Number |
DEN110006 |
510(K) Number |
K102469
|
Device Name |
VERIFY CRONOS SELF-CONTAINED BIOLOGICAL INDICATOR |
Requester |
steris corporation |
5960 heisley road |
mentor,
OH
44060
|
|
Contact |
robert sullivan |
|
Regulation Number | 880.2805
|
Classification Product Code |
|
Date Received | 09/06/2011 |
Decision Date | 07/12/2013 |
Decision |
granted
(DENG) |
Classification Advisory Committee |
General Hospital
|
Review Advisory Committee |
General Hospital
|
Type |
Post-NSE
|
|
|