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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Splint, Temporary Training
510(k) Number K770890
Device Name SPLINT, COCKUP
Applicant
Orthopedic Systems, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Orthopedic Systems, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number890.3025
Classification Product Code
IQM  
Date Received05/16/1977
Decision Date 05/26/1977
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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