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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 K943293
Device Name SCC22/ SCC26 SHOWER COMMODE CHAIR
Applicant
O'Tec Corp.
P.O. Box 320
204 W. 2nd St.
Ellis,  KS  67637
Applicant Contact LEE FRICKEY
Correspondent
O'Tec Corp.
P.O. Box 320
204 W. 2nd St.
Ellis,  KS  67637
Correspondent Contact LEE FRICKEY
Regulation Number890.3850
Classification Product Code
IOR  
Subsequent Product Code
ILS  
Date Received07/08/1994
Decision Date 08/19/1994
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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