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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 K943905
Device Name PRO-CRYLIC RESIN, TECHNICOLOR PRE-MIX MONOMER
Applicant
Professional Positioners, Inc.
2525 Three Mile Rd.
Racine,  WI  53404
Applicant Contact SANDRA IVANOSKI
Correspondent
Professional Positioners, Inc.
2525 Three Mile Rd.
Racine,  WI  53404
Correspondent Contact SANDRA IVANOSKI
Regulation Number872.3760
Classification Product Code
EBI  
Date Received08/11/1994
Decision Date 02/27/1995
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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