EVICEL APPLICATION DEVICE

Syringe, Piston

OMRIX BIOPHARMACEUTICALS LTD.

The following data is part of a premarket notification filed by Omrix Biopharmaceuticals Ltd. with the FDA for Evicel Application Device.

Pre-market Notification Details

Device IDK070575
510k NumberK070575
Device Name:EVICEL APPLICATION DEVICE
ClassificationSyringe, Piston
Applicant OMRIX BIOPHARMACEUTICALS LTD. MDA BLOOD BANK SHEBA HOSPITAL, TEL HASHOMER Ramat Gan,  IL 52621
ContactDavid Nakar
CorrespondentDavid Nakar
OMRIX BIOPHARMACEUTICALS LTD. MDA BLOOD BANK SHEBA HOSPITAL, TEL HASHOMER Ramat Gan,  IL 52621
Product CodeFMF  
CFR Regulation Number880.5860 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-02-28
Decision Date2007-05-29

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