Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K012889
Device Classification Name
Sterilant, Medical Devices
More FDA Info for this Device
510(K) Number
K012889
Device Name
Sterilant, Medical Devices
Applicant
PASCAL CO., INC.
1001 G STREET, N.W.
SUITE 500 WEST
WASHINGTON, DC 20001 US
Other 510(k) Applications for this Company
Contact
DAVID R JOY
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
08/28/2001
Decision Date
05/27/2003
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