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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Resin, Denture, Relining, Repairing, Rebasing
510(k) Number K953589
Device Name TOKUYAMA SOFT RELINING
Applicant
Tokuyama America, Inc.
C/O Graham & James
2000 M St., NW, Suite 700
Washington,  DC  20036
Applicant Contact DANIEL J MANELLI
Correspondent
Tokuyama America, Inc.
C/O Graham & James
2000 M St., NW, Suite 700
Washington,  DC  20036
Correspondent Contact DANIEL J MANELLI
Regulation Number872.3760
Classification Product Code
EBI  
Date Received08/01/1995
Decision Date 01/18/1996
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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