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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Barrier, Animal Source, Intraoral
510(k) Number K101453
Device Name VITALA NATURAL RESORBABLE COLLAGEN MEMBRANE
Applicant
OBI BIOLOGICS, INC.
4620 71ST STREET, BLDG 79
LUBBOCK,  TX  79424
Applicant Contact DUSTYN WEBB
Correspondent
OBI BIOLOGICS, INC.
4620 71ST STREET, BLDG 79
LUBBOCK,  TX  79424
Correspondent Contact DUSTYN WEBB
Regulation Number872.3930
Classification Product Code
NPL  
Date Received05/25/2010
Decision Date 07/21/2011
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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