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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Image Processing, Radiological
510(k) Number K071599
Device Name EASYGUIDE
Applicant
Keystone Dental, Inc.
161 Little Bay Rd.
Newington,  NH 
Applicant Contact MARTIN J LEIGHTON
Correspondent
Keystone Dental, Inc.
161 Little Bay Rd.
Newington,  NH 
Correspondent Contact MARTIN J LEIGHTON
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received06/11/2007
Decision Date 07/11/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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