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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Remover, Crown
510(k) Number K854795
Device Name HAZELTON TEMPORARY CROWN AND BRIDGE REMOVER
Applicant
Fran Hazelton Co.
919 First St.
Orland,  CA  95963
Applicant Contact FRANCES M HAZELTON
Correspondent
Fran Hazelton Co.
919 First St.
Orland,  CA  95963
Correspondent Contact FRANCES M HAZELTON
Regulation Number872.4565
Classification Product Code
EIS  
Date Received12/02/1985
Decision Date 03/04/1986
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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