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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Burnisher, Operative
510(k) Number K925115
Device Name AMD DENTIST AND HYGIENIST KITS
Applicant
Advance Medical Designs, Inc.
808 Pickens Industrial Dr.
Marietta,  GA  30062
Applicant Contact RONALD D ARKIN
Correspondent
Advance Medical Designs, Inc.
808 Pickens Industrial Dr.
Marietta,  GA  30062
Correspondent Contact RONALD D ARKIN
Regulation Number872.4565
Classification Product Code
EKJ  
Date Received10/09/1992
Decision Date 07/05/1994
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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