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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Components, Wheelchair
510(k) Number K923186
Device Name NEXUS WHEELCHAIR CUSHION/FORMERLY BIOTHOTIC
Applicant
Roho, Inc.
100 Florida Ave.
Belleville,  IL  62221
Applicant Contact OTTO D ROBERTS
Correspondent
Roho, Inc.
100 Florida Ave.
Belleville,  IL  62221
Correspondent Contact OTTO D ROBERTS
Regulation Number890.3920
Classification Product Code
KNN  
Date Received06/30/1992
Decision Date 09/09/1992
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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