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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 K771630
Device Name LIMB RESTRAINT
Applicant
Medical Restraints, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Medical Restraints, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number880.6760
Classification Product Code
FMQ  
Date Received08/26/1977
Decision Date 09/30/1977
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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