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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name table, radiographic, tilting
510(k) Number K920742
Device Name HYDRAJUST IV UROLOGICAL TABLE
Applicant
MALLINCKRODT GROUP, INC.
2111 EAST GALBRAITH RD.
P.O. BOX 156305
CINCINNATI,  OH  45215 -6305
Applicant Contact MARK L FREIDMAN
Correspondent
MALLINCKRODT GROUP, INC.
2111 EAST GALBRAITH RD.
P.O. BOX 156305
CINCINNATI,  OH  45215 -6305
Correspondent Contact MARK L FREIDMAN
Regulation Number892.1980
Classification Product Code
IXR  
Date Received02/19/1992
Decision Date 04/27/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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