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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wax, Bone
510(k) Number K153095
Device Name ROP Resorbable Hemostasis Material
Applicant
Resorbable Orthopedic Products, LLC
16633 Dallas Pkwy., Suite 250
Addison,  TX  75001
Applicant Contact Barry E Constantine
Correspondent
Trisler Consulting
5600 Wisconsin Ave.
Chevy Chase,  MD  20815
Correspondent Contact Patsy J Trisler
Classification Product Code
MTJ  
Date Received10/26/2015
Decision Date 02/17/2016
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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