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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
Applicant
Aesculap, Inc.
3 773 Corporate Pkwy.
Center Valley,  PA  18034
Applicant Contact DENISE ADAMS
Correspondent
Aesculap, Inc.
3 773 Corporate Pkwy.
Center Valley,  PA  18034
Correspondent Contact DENISE ADAMS
Regulation Number882.5910
Classification Product Code
GXQ  
Date Received09/12/2012
Decision Date 06/04/2013
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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