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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Splint, Hand, And Components
510(k) Number K823165
Device Name WRIST SPLING & FOREARM SPLINT
Applicant
Warm & Form, Orthopedic Materials
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Warm & Form, Orthopedic Materials
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number890.3475
Classification Product Code
ILH  
Date Received10/25/1982
Decision Date 11/16/1982
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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