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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Image Processing, Radiological
510(k) Number K021072
Device Name FILMSAVER, NT VERSION 5.03
Applicant
American Medical Resources, Ltd. (Amr)
3501 Silverside Rd. Suite 205
Wilmington,  DE  19810
Applicant Contact ELIZABETH N FAULSTICH
Correspondent
American Medical Resources, Ltd. (Amr)
3501 Silverside Rd. Suite 205
Wilmington,  DE  19810
Correspondent Contact ELIZABETH N FAULSTICH
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received04/02/2002
Decision Date 06/06/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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