STERILE FIELD SALINE AND HEPARIN LOCK FLUSH SYRINGES

Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days

EXCELSIOR MEDICAL CORP.

The following data is part of a premarket notification filed by Excelsior Medical Corp. with the FDA for Sterile Field Saline And Heparin Lock Flush Syringes.

Pre-market Notification Details

Device IDK053120
510k NumberK053120
Device Name:STERILE FIELD SALINE AND HEPARIN LOCK FLUSH SYRINGES
ClassificationCatheter, Intravascular, Therapeutic, Short-term Less Than 30 Days
Applicant EXCELSIOR MEDICAL CORP. 1923 HECK AVE. Neptune,  NJ  07753
ContactRuben Martinez
CorrespondentRuben Martinez
EXCELSIOR MEDICAL CORP. 1923 HECK AVE. Neptune,  NJ  07753
Product CodeFOZ  
CFR Regulation Number880.5200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-11-07
Decision Date2005-12-09
Summary:summary

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