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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Restraint, Protective
510(k) Number K925924
Device Name NEAL WRIST CONES
Applicant
Neal & Assoc., Inc.
6005 N. Gregory Dr.
Columbia,  MO  65202
Applicant Contact CAROL NEAL
Correspondent
Neal & Assoc., Inc.
6005 N. Gregory Dr.
Columbia,  MO  65202
Correspondent Contact CAROL NEAL
Regulation Number880.6760
Classification Product Code
FMQ  
Date Received11/23/1992
Decision Date 04/08/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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