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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Alloy, Other Noble Metal
510(k) Number K791973
Device Name HOWMEDICA A-35 DENTAL ALLOY
Applicant
Howmedica Corp.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Howmedica Corp.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number872.3060
Classification Product Code
EJS  
Date Received10/02/1979
Decision Date 11/20/1979
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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