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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Chair, Positioning, Electric
510(k) Number K880398
Device Name POWER TOILET ELEVATOR
Applicant
Med-West, Inc.
702 S. Third Ave.
P.O. Box 130
Marshalltown,  IA  50158
Applicant Contact VAL RUFF
Correspondent
Med-West, Inc.
702 S. Third Ave.
P.O. Box 130
Marshalltown,  IA  50158
Correspondent Contact VAL RUFF
Regulation Number890.3110
Classification Product Code
INO  
Date Received01/29/1988
Decision Date 03/17/1988
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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