HYDRADJUST IV UROLOGICAL TABLE

Table, Radiographic, Tilting

MALLINCKRODT GROUP, INC.

The following data is part of a premarket notification filed by Mallinckrodt Group, Inc. with the FDA for Hydradjust Iv Urological Table.

Pre-market Notification Details

Device IDK943581
510k NumberK943581
Device Name:HYDRADJUST IV UROLOGICAL TABLE
ClassificationTable, Radiographic, Tilting
Applicant MALLINCKRODT GROUP, INC. 2111 EAST GALBRAITH RD. P.O. BOX 156305 Cincinnati,  OH  45215 -6305
ContactM.l. Friedman
CorrespondentM.l. Friedman
MALLINCKRODT GROUP, INC. 2111 EAST GALBRAITH RD. P.O. BOX 156305 Cincinnati,  OH  45215 -6305
Product CodeIXR  
CFR Regulation Number892.1980 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-07-22
Decision Date1995-01-04

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10746190002451 K943581 000
10746190002444 K943581 000

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