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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Holder, Radiographic Cassette, Wall-Mounted
510(k) Number K891395
Device Name RADKOR BS-10 AND BS-10T
Applicant
Radkor, Inc.
16610 Aston St.
Irvine,  CA  92714
Applicant Contact JACK E BRIGGS
Correspondent
Radkor, Inc.
16610 Aston St.
Irvine,  CA  92714
Correspondent Contact JACK E BRIGGS
Regulation Number892.1880
Classification Product Code
IXY  
Date Received03/14/1989
Decision Date 04/03/1989
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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