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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cushion, Flotation
510(k) Number K861327
Device Name ROHO HEEL PAD
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 Number890.3175
Classification Product Code
KIC  
Date Received04/09/1986
Decision Date 06/02/1986
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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