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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bed, Air Fluidized
510(k) Number K911246
Device Name THE MEDISCUS PEDCARE MANAGEMENT SYSTEM-MODEL 2
Applicant
The Medical Group, Inc.
P.O. Box 5067
Buena Park,  CA  90620
Applicant Contact HELEN RAEEFSEMO
Correspondent
The Medical Group, Inc.
P.O. Box 5067
Buena Park,  CA  90620
Correspondent Contact HELEN RAEEFSEMO
Regulation Number890.5160
Classification Product Code
INX  
Date Received03/21/1991
Decision Date 06/06/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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