EXCELSIOR DISPOSABLE SYRINGE W/NORMAL SALINE (.9% SODIUM CHLORIDE)

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 Excelsior Disposable Syringe W/normal Saline (.9% Sodium Chloride).

Pre-market Notification Details

Device IDK962938
510k NumberK962938
Device Name:EXCELSIOR DISPOSABLE SYRINGE W/NORMAL SALINE (.9% SODIUM CHLORIDE)
ClassificationCatheter, Intravascular, Therapeutic, Short-term Less Than 30 Days
Applicant EXCELSIOR MEDICAL CORP. P.O. BOX 299 Long Branch,  NJ  07740 -0299
ContactDavid Lumia
CorrespondentDavid Lumia
EXCELSIOR MEDICAL CORP. P.O. BOX 299 Long Branch,  NJ  07740 -0299
Product CodeFOZ  
CFR Regulation Number880.5200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-07-29
Decision Date1996-10-25

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.