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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name restraint, protective
510(k) Number K963471
Device Name SUPER SECURITY RESTRAINT
Applicant
DEROYAL INDUSTRIES, INC.
200 DEBUSK LN.
POWELL,  TN  37849
Applicant Contact CAMILLE MATLOCK
Correspondent
DEROYAL INDUSTRIES, INC.
200 DEBUSK LN.
POWELL,  TN  37849
Correspondent Contact CAMILLE MATLOCK
Regulation Number880.6760
Classification Product Code
FMQ  
Date Received09/03/1996
Decision Date 11/14/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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