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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Barrier, Synthetic, Intraoral
510(k) Number K171774
Device Name RPM Reinforced PTFE Mesh
Applicant
Osteogenics Biomedical, Inc.
4620 71st St. Bldg. 78-79
Lubbock,  TX  79424
Applicant Contact Shane Shuttlesworth
Correspondent
Osteogenics Biomedical, Inc.
4620 71st St. Bldg. 78-79
Lubbock,  TX  79424
Correspondent Contact Shane Shuttlesworth
Regulation Number872.3930
Classification Product Code
NPK  
Subsequent Product Code
JEY  
Date Received06/14/2017
Decision Date 10/19/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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