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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 K905789
Device Name FRANKLIN 9000 WALL STAND
Applicant
Mallinckrodt Group, Inc.
2111 E. Galbraith Rd.
P.O. Box 156305
Cincinnati,  OH  45215
Applicant Contact THOMAS DONOHUE
Correspondent
Mallinckrodt Group, Inc.
2111 E. Galbraith Rd.
P.O. Box 156305
Cincinnati,  OH  45215
Correspondent Contact THOMAS DONOHUE
Regulation Number892.1860
Classification Product Code
KPX  
Date Received12/27/1990
Decision Date 05/20/1991
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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