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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Handpiece, Water-Powered
510(k) Number K896364
Device Name DECIDENT
Applicant
Nevin Laboratories, Inc.
5000 S. Halsted St.
Chicago,  IL  60609
Applicant Contact ROBERT L NEVIN
Correspondent
Nevin Laboratories, Inc.
5000 S. Halsted St.
Chicago,  IL  60609
Correspondent Contact ROBERT L NEVIN
Regulation Number872.4200
Classification Product Code
EKY  
Date Received11/06/1989
Decision Date 07/19/1990
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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