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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Material, Impression Tray, Resin
510(k) Number K901782
Device Name CONVERTRAY CUSTOM IMPRESSION TRAY MATERIAL SYSTEM
Applicant
Productivity Training Corp.
168 # Michigan Ave.
Suite 800
Chicago,  IL  60602
Applicant Contact ROBERT W BAUER
Correspondent
Productivity Training Corp.
168 # Michigan Ave.
Suite 800
Chicago,  IL  60602
Correspondent Contact ROBERT W BAUER
Regulation Number872.3670
Classification Product Code
EBH  
Date Received04/17/1990
Decision Date 06/29/1990
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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