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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cassette, Radiographic Film
510(k) Number K023020
Device Name AGFA MAMORAY MAMMOGRAPHIC CASSETTE, AGFA METAL-BODIED CAWO CASSETTE, AGFA CURIX AND LIGHTWEIGHT CASSETTE
Applicant
AGFA CORP.
10 SOUTH ACADEMY ST.
GREENVILLE,  SC  29601
Applicant Contact PAMELA K GWYNN
Correspondent
UNDERWRITERS LABORATORIES, INC.
12 LABORATORY DR.
RESEARCH TRIANGLE,  NC  27709
Regulation Number892.1850
Classification Product Code
IXA  
Date Received09/11/2002
Decision Date 09/26/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Recalls CDRH Recalls
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