Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K141238
Device Classification Name
Indicator, Biological Sterilization Process
More FDA Info for this Device
510(K) Number
K141238
Device Name
Indicator, Biological Sterilization Process
Applicant
STERILUCENT, INC
1400 MARSHALL STREET NE
MINNEAPOLIS, MN 55413 US
Other 510(k) Applications for this Company
Contact
PETER KALKBRENNER
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
05/13/2014
Decision Date
11/03/2014
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