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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Stand, Infusion
510(k) Number K944580
Device Name FLEXSYS MOBILEMATE EQUIPMENT STAND
Applicant
Hill-Rom, Inc.
1069 State Rt. 46 E.
Batesville,  IN  47006
Applicant Contact JAMES G CARPENTER
Correspondent
Hill-Rom, Inc.
1069 State Rt. 46 E.
Batesville,  IN  47006
Correspondent Contact JAMES G CARPENTER
Regulation Number880.6990
Classification Product Code
FOX  
Date Received09/19/1994
Decision Date 03/17/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized
No
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