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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Scaler, Ultrasonic
510(k) Number K070975
Device Name SYMMETRY IQ, MODEL 2000 SERIES, 3000 SERIES
Applicant
Hu-Friedy Mfg. Co., Inc.
3232 N Rockwell St.
Chicago,  IL  60618
Applicant Contact KEITH DUNN
Correspondent
Hu-Friedy Mfg. Co., Inc.
3232 N Rockwell St.
Chicago,  IL  60618
Correspondent Contact KEITH DUNN
Regulation Number872.4850
Classification Product Code
ELC  
Date Received04/06/2007
Decision Date 06/21/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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