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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 K962626
Device Name PATIENT PROTECTIVE LIMB
Applicant
Kenad SG Medical, Inc.
2692 Huntley Dr.
Memphis,  TN  38132
Applicant Contact KENNETH ELMORE
Correspondent
Kenad SG Medical, Inc.
2692 Huntley Dr.
Memphis,  TN  38132
Correspondent Contact KENNETH ELMORE
Regulation Number880.6760
Classification Product Code
FMQ  
Date Received07/05/1996
Decision Date 10/02/1996
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
Predetermined Change
Control Plan Authorized		 No
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