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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 K862930
Device Name PERFECT ONE
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 Received08/04/1986
Decision Date 10/24/1986
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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