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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 K954802
Device Name RITE-ANGLE DISPOSABLE PROPHY ANGLES
Applicant
Ash-USA
570 W. College Ave.
York,  PA  17404
Applicant Contact P. JEFFERY LEHN
Correspondent
Ash-USA
570 W. College Ave.
York,  PA  17404
Correspondent Contact P. JEFFERY LEHN
Regulation Number872.4200
Classification Product Code
EGS  
Date Received10/19/1995
Decision Date 11/08/1995
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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