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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
Predetermined Change
Control Plan Authorized		 No
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