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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Amalgamator, Dental, Ac-Powered
510(k) Number K910632
Device Name ACCU-MIX AMALGAMATOR
Applicant
Wykle Research, Inc.
2222 Hot Springs Rd.
Carson City,  NV  89706
Applicant Contact MAURICE M WEIKEL
Correspondent
Wykle Research, Inc.
2222 Hot Springs Rd.
Carson City,  NV  89706
Correspondent Contact MAURICE M WEIKEL
Regulation Number872.3100
Classification Product Code
EFD  
Date Received02/13/1991
Decision Date 03/15/1991
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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