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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 K933745
Device Name PERMAGEN UNIVERSAL BONDING RESIN
Applicant
Bio-Systems Research
2057 Summit Dr.
Lake Oswego,  OR  97034
Applicant Contact ARTHUR J SAFFIR
Correspondent
Bio-Systems Research
2057 Summit Dr.
Lake Oswego,  OR  97034
Correspondent Contact ARTHUR J SAFFIR
Regulation Number872.3670
Classification Product Code
EBH  
Date Received08/03/1993
Decision Date 01/26/1994
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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