Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K020875
Device Classification Name
Sterilizer, Ethylene-Oxide Gas
More FDA Info for this Device
510(K) Number
K020875
Device Name
Sterilizer, Ethylene-Oxide Gas
Applicant
TECHNOLOGIES OF STERILIZATION WITH OXONE, TSO3 INC
33 BLACK WATCH TRAIL
FAIRPORT, NY 14450 US
Other 510(k) Applications for this Company
Contact
CHARLES O HANCOCK
Other 510(k) Applications for this Contact
Regulation Number
880.6860
More FDA Info for this Regulation Number
Classification Product Code
FLF
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
03/18/2002
Decision Date
08/26/2003
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