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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 K926165
Device Name CERAMCO CROWNS AND BRIDGES
Applicant
Asap Dental Lab, Ltd.
1067 Union Ave.
Newburgh,  NY  12550
Applicant Contact GEORGE FREUD
Correspondent
Asap Dental Lab, Ltd.
1067 Union Ave.
Newburgh,  NY  12550
Correspondent Contact GEORGE FREUD
Regulation Number872.3710
Classification Product Code
EJH  
Date Received12/08/1992
Decision Date 03/31/1994
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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