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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 K151344
Device Name Cytoflex Tefguard Ti-Enforced Membrane
Applicant
Unicare Biomedical, Inc.
23011 Moulton Parkway, J-11
Laguna Hills,  CA  92653
Applicant Contact Stan Yang
Correspondent
Unicare Biomedical, Inc.
23011 Moulton Parkway, J-11
Laguna Hills,  CA  92653
Correspondent Contact Stan Yang
Regulation Number872.3930
Classification Product Code
NPK  
Date Received05/19/2015
Decision Date 11/19/2015
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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