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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Alloy, Metal, Base
510(k) Number K023477
Device Name BIOLOY
Applicant
Neirynck & Vogt NV
12960 Stonecreek Dr.
Suite C
Pickerington,  OH  43147
Applicant Contact JOSH ANDRACHEK
Correspondent
Neirynck & Vogt NV
12960 Stonecreek Dr.
Suite C
Pickerington,  OH  43147
Correspondent Contact JOSH ANDRACHEK
Regulation Number872.3710
Classification Product Code
EJH  
Date Received10/16/2002
Decision Date 12/13/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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