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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 K053173
Device Name DS CASSETTE
Applicant
Konica Minolta Medical & Graphic, Inc.
319 Akeno
Obata-Cho, Watarai-Gun
Mie-Ken,  JP 519-05
Applicant Contact SHINICHI YAMANAKA
Correspondent
Konica Minolta Medical & Graphic, Inc.
319 Akeno
Obata-Cho, Watarai-Gun
Mie-Ken,  JP 519-05
Correspondent Contact SHINICHI YAMANAKA
Regulation Number892.1850
Classification Product Code
IXA  
Date Received11/14/2005
Decision Date 12/15/2005
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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