Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K133446
Device Classification Name
Heparin, Vascular Access Flush
More FDA Info for this Device
510(K) Number
K133446
Device Name
Heparin, Vascular Access Flush
Applicant
Excelsior Medical Corporation
1933 HECK AVE
NEPTUNE, NJ 07753 US
Other 510(k) Applications for this Company
Contact
JOHN LINFANTE
Other 510(k) Applications for this Contact
Regulation Number
880.5200
More FDA Info for this Regulation Number
Classification Product Code
NZW
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
11/12/2013
Decision Date
11/14/2014
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