Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K071418
Device Classification Name
Accessories, Pump, Infusion
More FDA Info for this Device
510(K) Number
K071418
Device Name
Accessories, Pump, Infusion
Applicant
SOOIL DEVELOPMENT CO., LTD.
49 PLAIN STREET
NORTH ATTLEBORO, MA 02760 US
Other 510(k) Applications for this Company
Contact
CYNTHIA NOLTE, PH.D
Other 510(k) Applications for this Contact
Regulation Number
880.5725
More FDA Info for this Regulation Number
Classification Product Code
MRZ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
05/22/2007
Decision Date
09/04/2007
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