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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 K133507
Device Name GUIDOSS
Applicant
NIBEC CO LTD
4568 W. 1ST STREET, STE 104
LOS ANGELES,  CA  90004
Applicant Contact DANIEL NAM
Correspondent
NIBEC CO LTD
4568 W. 1ST STREET, STE 104
LOS ANGELES,  CA  90004
Correspondent Contact DANIEL NAM
Regulation Number872.3930
Classification Product Code
NPL  
Date Received11/14/2013
Decision Date 11/05/2014
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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