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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Hand, External Limb Component, Mechanical
510(k) Number K821619
Device Name THE SPORTS HAND
Applicant
Therapeutic Recreation Systems, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Therapeutic Recreation Systems, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number890.3420
Classification Product Code
IRA  
Date Received06/02/1982
Decision Date 07/20/1982
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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