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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 K901175
Device Name HAND MIRROR
Applicant
American Medical Ceramics, Inc.
408 Cedar Bluff Rd., Suite
385
Knoxville,  TN  37923
Applicant Contact SAM C WEAVER
Correspondent
American Medical Ceramics, Inc.
408 Cedar Bluff Rd., Suite
385
Knoxville,  TN  37923
Correspondent Contact SAM C WEAVER
Regulation Number872.4565
Classification Product Code
EKJ  
Date Received03/13/1990
Decision Date 04/16/1990
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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