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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Table, Obstetric (And Accessories)
510(k) Number K915779
Device Name AFFINITY BED MODEL 3600 SERIES
Applicant
Hill-Rom, Inc.
1069 E. Rt 46
Batesville,  IN  47006
Applicant Contact JAMES G CARPENTER
Correspondent
Hill-Rom, Inc.
1069 E. Rt 46
Batesville,  IN  47006
Correspondent Contact JAMES G CARPENTER
Regulation Number884.4900
Classification Product Code
KNC  
Date Received12/24/1991
Decision Date 02/24/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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