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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 K141177
Device Name VITALA PORCINE DERIVED COLLAGEN MEMBRANE
Applicant
OSTEOGENICS BIOMEDICAL, INC. (FORMERLY OBI BIOLOGI
4620 71ST ST, BLDG 78
LUBBOCK,  TX  79424
Applicant Contact SHANE SHUTTLESWORTH
Correspondent
OSTEOGENICS BIOMEDICAL, INC. (FORMERLY OBI BIOLOGI
4620 71ST ST, BLDG 78
LUBBOCK,  TX  79424
Correspondent Contact SHANE SHUTTLESWORTH
Regulation Number872.3930
Classification Product Code
NPL  
Date Received05/07/2014
Decision Date 09/15/2015
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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