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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 K960809
Device Name PHILIPS SITE VIEW WORKSTATION
Applicant
Philips Medical Systems North America, Inc.
710 Bridgeport Ave.
Shelton,  CT  06484
Applicant Contact TIMOTHY W CAPEHART
Correspondent
Philips Medical Systems North America, Inc.
710 Bridgeport Ave.
Shelton,  CT  06484
Correspondent Contact TIMOTHY W CAPEHART
Regulation Number892.2020
Classification Product Code
LMD  
Date Received02/28/1996
Decision Date 04/07/1996
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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