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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Needle, Hypodermic, Single Lumen
510(k) Number K030032
Device Name CROSSEAL APPLICATION DEVICE
Applicant
Omrix Biopharmaceuticals, Inc.
6599 Commerce Ct.
Suite 200
Warrington,  VA  20187
Applicant Contact SUE BHADARE
Correspondent
Omrix Biopharmaceuticals, Inc.
6599 Commerce Ct.
Suite 200
Warrington,  VA  20187
Correspondent Contact SUE BHADARE
Regulation Number880.5570
Classification Product Code
FMI  
Date Received01/03/2003
Decision Date 03/21/2003
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
Recalls CDRH Recalls
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