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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 K945834
Device Name PROPHY PRO.
Applicant
Hyman, Phelps & McNamara, P.C.
700 13th St. NW Suite 1200
Washington Dc,  DC  20005
Applicant Contact KENNETH A OLSEN
Correspondent
Hyman, Phelps & McNamara, P.C.
700 13th St. NW Suite 1200
Washington Dc,  DC  20005
Correspondent Contact KENNETH A OLSEN
Regulation Number872.4200
Classification Product Code
EGS  
Date Received11/29/1994
Decision Date 02/13/1995
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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