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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Pin, Retentive And Splinting, And Accessory Instruments
510(k) Number K883074
Device Name ELGILOY
Applicant
Dale T. Dupuis
912 N. Union
Opelousas,  LA  70570
Applicant Contact DUPUIS, DDS
Correspondent
Dale T. Dupuis
912 N. Union
Opelousas,  LA  70570
Correspondent Contact DUPUIS, DDS
Regulation Number872.3740
Classification Product Code
EBL  
Date Received07/14/1988
Decision Date 08/09/1988
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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