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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 K862695
Device Name FLUOR-ETCH GEL ETCHANT
Applicant
Teledyne, Inc.
1550 Greenleaf Ave.
Elk Grove Village,  IL  60007
Applicant Contact JOHN WASHBURN
Correspondent
Teledyne, Inc.
1550 Greenleaf Ave.
Elk Grove Village,  IL  60007
Correspondent Contact JOHN WASHBURN
Regulation Number872.3765
Classification Product Code
EBC  
Date Received07/15/1986
Decision Date 07/31/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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