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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Solid State X-Ray Imager (Flat Panel/Digital Imager)
510(k) Number K052136
Device Name GR17 DIGITAL DETECTOR
Applicant
ANRAD CORP.
8 CENTENNIAL DRIVE
PEABODY,  MA  01960
Applicant Contact DONALD J SHERRATT
Correspondent
ANRAD CORP.
8 CENTENNIAL DRIVE
PEABODY,  MA  01960
Correspondent Contact DONALD J SHERRATT
Regulation Number892.1680
Classification Product Code
MQB  
Date Received08/05/2005
Decision Date 08/25/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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