Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K120685
Device Classification Name
Set, Administration, Intravascular
More FDA Info for this Device
510(K) Number
K120685
Device Name
Set, Administration, Intravascular
Applicant
ZYNO MEDICAL LLC
10 TECH CIRCLE
NATICK, MA 01760 US
Other 510(k) Applications for this Company
Contact
CHAOYOUNG LEE
Other 510(k) Applications for this Contact
Regulation Number
880.5440
More FDA Info for this Regulation Number
Classification Product Code
FPA
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
03/06/2012
Decision Date
09/07/2012
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
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact