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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
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