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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 K873661
Device Name CHROME-COBALT BASE DENTAL ALLOY
Applicant
NORTH AMERICAN ALLOYS, INC.
225 BRENTWOOD CT.
bloomingdale,  IL  60108
Applicant Contact kathleen calero
Correspondent
NORTH AMERICAN ALLOYS, INC.
225 BRENTWOOD CT.
bloomingdale,  IL  60108
Correspondent Contact kathleen calero
Regulation Number872.3710
Classification Product Code
EJH  
Date Received09/10/1987
Decision Date 11/16/1987
Decision substantially equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
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