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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dura Substitute
510(k) Number K061208
Device Name LIFECELL DURAL SUBSTITUTE MATRIX
Applicant
Lifecell Corp.
One Millenium Way
Branchburg,  NJ  08876
Applicant Contact REY LIBROJO
Correspondent
Lifecell Corp.
One Millenium Way
Branchburg,  NJ  08876
Correspondent Contact REY LIBROJO
Regulation Number882.5910
Classification Product Code
GXQ  
Date Received05/01/2006
Decision Date 01/03/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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