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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 K023953
Device Name ST. GEORGE TECHNOLOGY, INC PERFECTION PLUS DISPOSABLE PROPHY ANGLE
Applicant
St. George Technology, Inc.
P.O. Box 2849
Wilmington,  NC  28402
Applicant Contact VERNON WATKINS
Correspondent
St. George Technology, Inc.
P.O. Box 2849
Wilmington,  NC  28402
Correspondent Contact VERNON WATKINS
Regulation Number872.4200
Classification Product Code
EGS  
Date Received11/27/2002
Decision Date 02/14/2003
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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