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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wheelchair, Mechanical
510(k) Number K863892
Device Name THERACARE LOUNGER
Applicant
American Theracare
10022 Imperial Ave. Suite D
Garden Grove,  CA  92643
Applicant Contact DUNCAN M MILNE
Correspondent
American Theracare
10022 Imperial Ave. Suite D
Garden Grove,  CA  92643
Correspondent Contact DUNCAN M MILNE
Regulation Number890.3850
Classification Product Code
IOR  
Date Received10/06/1986
Decision Date 10/23/1986
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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