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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Handle, Instrument, Dental
510(k) Number K930094
Device Name AUKUSLEEVE
Applicant
Aukland Medical Plastics, Inc.
P.O. Box 5624
Cary,  NC  27512
Applicant Contact NORMAN A GRAY
Correspondent
Aukland Medical Plastics, Inc.
P.O. Box 5624
Cary,  NC  27512
Correspondent Contact NORMAN A GRAY
Regulation Number872.4565
Classification Product Code
EJB  
Date Received01/08/1993
Decision Date 10/20/1993
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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