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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stretcher, Wheeled, Powered
510(k) Number K112502
Device Name PROCEDURAL STRECHER WITH INTELLIDRIVE P8000
Applicant
Hill-Rom Co.
1069 State Rt. 46 E.
Batesville,  IN  47006 -9167
Applicant Contact CHAD HODSON
Correspondent
Intertek Testing Services
2307 E. Aurora Rd.
Unit B7
Twinsburg,  OH  44087
Correspondent Contact PAULA WILKERSON
Regulation Number890.3690
Classification Product Code
INK  
Date Received08/30/2011
Decision Date 09/19/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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