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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Changer, Radiographic Film/Cassette
510(k) Number K925169
Device Name SHIMADZU RADIOGRAPJHIC STAND BR-100
Applicant
Shimadzu Medical Systems
101 W. Walnut St.
Gardena,  CA  90248
Applicant Contact DE MINT
Correspondent
Shimadzu Medical Systems
101 W. Walnut St.
Gardena,  CA  90248
Correspondent Contact DE MINT
Regulation Number892.1860
Classification Product Code
KPX  
Date Received10/13/1992
Decision Date 12/03/1992
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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