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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Syringe, Piston
510(k) Number K070575
Device Name EVICEL APPLICATION DEVICE
Applicant
OMRIX BIOPHARMACEUTICALS LTD.
MDA BLOOD BANK
SHEBA HOSPITAL, TEL HASHOMER
RAMAT GAN,  IL 52621
Applicant Contact DAVID NAKAR
Correspondent
OMRIX BIOPHARMACEUTICALS LTD.
MDA BLOOD BANK
SHEBA HOSPITAL, TEL HASHOMER
RAMAT GAN,  IL 52621
Correspondent Contact DAVID NAKAR
Regulation Number880.5860
Classification Product Code
FMF  
Date Received02/28/2007
Decision Date 05/29/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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