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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Resin, Root Canal Filling
510(k) Number K844635
Device Name HYDROSET ROOT CANAL SEALER
Applicant
Lund Manufacturing Co.
2151 Derringer Ln.
Diamond Bar,  CA  91765
Correspondent
Lund Manufacturing Co.
2151 Derringer Ln.
Diamond Bar,  CA  91765
Regulation Number872.3820
Classification Product Code
KIF  
Date Received11/28/1984
Decision Date 02/19/1985
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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