Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K112018
Device Classification Name
Indicator, Biological Sterilization Process
More FDA Info for this Device
510(K) Number
K112018
Device Name
Indicator, Biological Sterilization Process
Applicant
MESA LABORATORIES, INC.
10 EVERGREEN DRIVE
BOZEMAN, MT 59715 US
Other 510(k) Applications for this Company
Contact
WENDY ROYALTY
Other 510(k) Applications for this Contact
Regulation Number
880.2800
More FDA Info for this Regulation Number
Classification Product Code
FRC
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
07/14/2011
Decision Date
01/30/2012
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact