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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Handpiece, Contra- And Right-Angle Attachment, Dental
510(k) Number K923980
Device Name Q3 DISPOSABLE PROPHY ANGLE
Applicant
Q3 Special Products, Inc.
511 Sarah Ln.
St. Louis,  MO  63141
Applicant Contact DAVID KRAENZLE
Correspondent
Q3 Special Products, Inc.
511 Sarah Ln.
St. Louis,  MO  63141
Correspondent Contact DAVID KRAENZLE
Regulation Number872.4200
Classification Product Code
EGS  
Date Received08/07/1992
Decision Date 05/27/1993
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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