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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Digital Image Communications, Radiological
510(k) Number K964250
Device Name LINX NETWORKING SYSTEM
Applicant
Sterling Diagnostic Imaging, Inc.
P.O. Box 6101
Bldg. 600/Mailbox 630
Newark,  DE  19714 -6101
Applicant Contact JEAN E BARTLETT
Correspondent
Sterling Diagnostic Imaging, Inc.
P.O. Box 6101
Bldg. 600/Mailbox 630
Newark,  DE  19714 -6101
Correspondent Contact JEAN E BARTLETT
Regulation Number892.2020
Classification Product Code
LMD  
Date Received10/24/1996
Decision Date 12/18/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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