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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 K883034
Device Name WHEELCHAIR BCW 6000
Applicant
O'Tec Corp.
612 E. Ash
P.O. Box Drawer 30
Oberlin,  KS  67749
Applicant Contact STEVE P BRUNGARDT
Correspondent
O'Tec Corp.
612 E. Ash
P.O. Box Drawer 30
Oberlin,  KS  67749
Correspondent Contact STEVE P BRUNGARDT
Regulation Number890.3850
Classification Product Code
IOR  
Date Received07/19/1988
Decision Date 08/02/1988
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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