Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K091890
Device Classification Name
Sterilant, Medical Devices
More FDA Info for this Device
510(K) Number
K091890
Device Name
Sterilant, Medical Devices
Applicant
HEALTHPOINT, LTD.
3909 HULEN ST.
FORT WORTH, TX 76107 US
Other 510(k) Applications for this Company
Contact
AMY CAMPBELL
Other 510(k) Applications for this Contact
Regulation Number
880.6885
More FDA Info for this Regulation Number
Classification Product Code
MED
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
06/23/2009
Decision Date
03/24/2010
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