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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Screen, Leaded, Operator Radiation Protector
510(k) Number K944772
Device Name MULTIPLE ED1600 SERIES RADIATION SHIELDS
Applicant
Image Diagnostics, Inc.
98 Pratts Junction Rd.
Sterling,  MA  01564
Applicant Contact REMO J ROSSI
Correspondent
Image Diagnostics, Inc.
98 Pratts Junction Rd.
Sterling,  MA  01564
Correspondent Contact REMO J ROSSI
Regulation Number892.6500
Classification Product Code
EAK  
Date Received09/27/1994
Decision Date 10/20/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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