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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 K993344
Device Name P10 SPECIAL
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 Received10/05/1999
Decision Date 11/15/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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