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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Alloy, Metal, Base
510(k) Number K020062
Device Name XERAFIT
Applicant
Metalor Technologies USA
255 John L. Dietsch Blvd.
North Attleborough,  MA  02761
Applicant Contact BRUCE A BARTON
Correspondent
Metalor Technologies USA
255 John L. Dietsch Blvd.
North Attleborough,  MA  02761
Correspondent Contact BRUCE A BARTON
Regulation Number872.3710
Classification Product Code
EJH  
Date Received01/08/2002
Decision Date 02/14/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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