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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 K183513
Device Name XenoSure Dura Biologic Patch
Applicant
Lemaitre Vascular, Inc.
63 Second Ave.
Burlington,  MA  01803
Applicant Contact Xiang Zhang
Correspondent
Lemaitre Vascular, Inc.
63 Second Ave.
Burlington,  MA  01803
Correspondent Contact Xiang Zhang
Regulation Number882.5910
Classification Product Code
GXQ  
Date Received12/18/2018
Decision Date 06/13/2019
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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