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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 K122791
Device Name LYOPLANT ONLAY
Original Applicant
AESCULAP, INC.
3773 corporate parkway
center valley,  PA  18034
Original Contact denise adams
Regulation Number882.5910
Classification Product Code
GXQ  
Date Received09/12/2012
Decision Date 06/04/2013
Decision substantially equivalent (SE)
Classification Advisory Committee Neurology
Review Advisory Committee Neurology
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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