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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 K792012
Device Name SKIL-CARE SUPER-SOFT LIMB RESTRAINTS
Applicant
Skil-Care Corp.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Skil-Care Corp.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number880.6760
Classification Product Code
FMQ  
Date Received10/05/1979
Decision Date 10/26/1979
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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