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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 K130900
Device Name EVICEL APPLICATION DEVICE
Applicant
Ethicon Inc (On Behalf of Omrix Biopharaceuticals
Rte. 22 W.
Somerville,  NJ  08876
Applicant Contact SHIKHA GOLA
Correspondent
Ethicon Inc (On Behalf of Omrix Biopharaceuticals
Rte. 22 W.
Somerville,  NJ  08876
Correspondent Contact SHIKHA GOLA
Regulation Number880.5860
Classification Product Code
FMF  
Date Received04/01/2013
Decision Date 08/13/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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