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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Sealant, Pit And Fissure, And Conditioner
510(k) Number K021844
Device Name ADMIRA PROTECT
Applicant
Voco GmbH
19379 Blue Lake Loop
Bend,  OR  97702
Applicant Contact GERALD W SHIPPS
Correspondent
Voco GmbH
19379 Blue Lake Loop
Bend,  OR  97702
Correspondent Contact GERALD W SHIPPS
Regulation Number872.3765
Classification Product Code
EBC  
Date Received06/05/2002
Decision Date 07/19/2002
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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