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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Aid, Transfer
510(k) Number K823154
Device Name SHOWER STOOL W/HANDLES
Applicant
Orthion Corp.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Orthion Corp.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number890.5050
Classification Product Code
IKX  
Date Received10/20/1982
Decision Date 11/05/1982
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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