Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K141879
Device Classification Name
Sterilizer, Steam
More FDA Info for this Device
510(K) Number
K141879
Device Name
Sterilizer, Steam
Applicant
SAUTER AG
ZELGSTRASSE 8
SULGEN TG CH-8583 CH
Other 510(k) Applications for this Company
Contact
MICHAEL HARI
Other 510(k) Applications for this Contact
Regulation Number
880.6880
More FDA Info for this Regulation Number
Classification Product Code
FLE
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
07/11/2014
Decision Date
06/17/2015
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Summary
Type
Abbreviated
Reviewed By Third Party
N
Expedited Review
FDA Source Information for K141879
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact