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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Orthosis, Limb Brace
510(k) Number K926391
Device Name ACCUFLEX DYNAMIC ELBOW ORTHOSIS
Applicant
Regulatory & Marketing Services, Inc.
P.O. Box 2010
Palm Florida,  FL  34682
Applicant Contact PATRICK J LAMB
Correspondent
Regulatory & Marketing Services, Inc.
P.O. Box 2010
Palm Florida,  FL  34682
Correspondent Contact PATRICK J LAMB
Regulation Number890.3475
Classification Product Code
IQI  
Date Received12/21/1992
Decision Date 07/22/1993
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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