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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Alloy, Amalgam
510(k) Number K952670
Device Name CUPRALLOY
Applicant
Wykle Research, Inc.
2222 Hot Springs Rd.
Carson City,  NV  89706
Applicant Contact IRIS SHIMABUKURO
Correspondent
Wykle Research, Inc.
2222 Hot Springs Rd.
Carson City,  NV  89706
Correspondent Contact IRIS SHIMABUKURO
Regulation Number872.3070
Classification Product Code
EJJ  
Date Received06/12/1995
Decision Date 08/25/1995
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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