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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 K925864
Device Name COURIER PC
Applicant
Shoreline Business Consulting
92 Knollwood Dr.
Old Saybrook,  CT  06475
Applicant Contact KENNETH BURGESS
Correspondent
Shoreline Business Consulting
92 Knollwood Dr.
Old Saybrook,  CT  06475
Correspondent Contact KENNETH BURGESS
Regulation Number892.2020
Classification Product Code
LMD  
Date Received11/19/1992
Decision Date 09/20/1993
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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