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510(k) K133446

Device
HEPARIN LOCK / FLUSH SYRINGES
Applicant
Excelsior Medical Corporation
510(k) number
K133446
Product code
NZW  
Decision
Substantially Equivalent (SESE)
Decision date
2014-11-14
Date received
2013-11-12
Regulation
880.5200
Classification name
Heparin, Vascular Access Flush
Medical specialty
General Hospital
Review panel
General Hospital
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
JOHN LINFANTE
Address
1933 Heck Ave. Neptune NJ US 07753 07753

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code NZW  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K163591BD PosiFlush Heparin Lock Flush SyringeBecton, Dickinson and Company2017-02-27
K092938HEPARIN LOCK FLUSH SOLUTION USP, MODELS 504401, 504411, 504505, 505701, 504901, 1710App Pharmaceuticals, LLC2010-06-18
K092491MEDEFIL'S HEPARIN I.V. FLUSH SYRINGE 1 UNIT/ML; 10 UNITS/ML; AND 100 UNITS/ML IN VARIOUS FILL SIZESMedefil, Inc.2010-02-03
K090680HEPARIN LOCK FLUSH SOLUTION, USP BD POSIFLUSH HEPARIN LOCK FLUSH SYRINGEBecton, Dickinson & CO2009-06-10
K061497SYREX HEPARIN LOCK FLUSH SYRINGE, 1 UNIT/ML & 2 UNITS/MLExcelsior Medical Corp.2007-02-23
K023740SYREX PRE-FILLED SYRINGEExcelsior Medical Corp.2003-05-13

Legacy Summary#

summary

FDA Review#

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