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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
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