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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 K890494
Device Name FLUOREVER PIT AND FISSURE SEALANT OR FLUOREVER PFS
Applicant
Macrochem Corp.
9 Linnell Cir.
Billerica,  MA  01820
Applicant Contact WOLTER, MD
Correspondent
Macrochem Corp.
9 Linnell Cir.
Billerica,  MA  01820
Correspondent Contact WOLTER, MD
Regulation Number872.3765
Classification Product Code
EBC  
Date Received01/31/1989
Decision Date 03/29/1989
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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