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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Restraint, Wheelchair, Non-Protective
510(k) Number K963480
Device Name MULTI-PURPOSE UTILITY RESTRAINT/BODY HOLDER
Applicant
Deroyal Industries, Inc.
200 Debusk Ln.
Knoxville,  TN  37849
Applicant Contact CAMILLE MATLOCK
Correspondent
Deroyal Industries, Inc.
200 Debusk Ln.
Knoxville,  TN  37849
Correspondent Contact CAMILLE MATLOCK
Regulation Number890.3910
Classification Product Code
KID  
Date Received09/03/1996
Decision Date 01/22/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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