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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name System, X-Ray, Angiographic
510(k) Number K961451
Device Name DICOMNET
Applicant
Lockheed Martin Communications Systems
1 Federal St.
Camden,  NJ  08103
Applicant Contact VINCENT J NAPOLEON
Correspondent
Lockheed Martin Communications Systems
1 Federal St.
Camden,  NJ  08103
Correspondent Contact VINCENT J NAPOLEON
Regulation Number892.1600
Classification Product Code
IZI  
Date Received04/16/1996
Decision Date 07/03/1996
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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