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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Condenser, Amalgam And Foil, Operative
510(k) Number K865025
Device Name AUSTENAL CONDENSING INSTRUMENT
Applicant
Austenal Dental, Inc.
5101 S. Keeler Ave.
Chicago,  IL  60632
Applicant Contact JOHAN HULTEN
Correspondent
Austenal Dental, Inc.
5101 S. Keeler Ave.
Chicago,  IL  60632
Correspondent Contact JOHAN HULTEN
Regulation Number872.4565
Classification Product Code
EKG  
Date Received12/23/1986
Decision Date 02/19/1987
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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