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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Handpiece, Air-Powered, Dental
510(k) Number K921564
Device Name POLYCLEAN
Applicant
Medical Polymers, Inc.
8920 Business Park Dr.
Suite 290
Austin,  TX  78759
Applicant Contact ANNE CROSSWAY
Correspondent
Medical Polymers, Inc.
8920 Business Park Dr.
Suite 290
Austin,  TX  78759
Correspondent Contact ANNE CROSSWAY
Regulation Number872.4200
Classification Product Code
EFB  
Date Received04/01/1992
Decision Date 08/10/1992
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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