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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 K010644
Device Name CINCH-TYPE DISPOSABLE LIMB HOLDERS, MODEL 912025
Applicant
Skil-Care Corp.
29 Wells Ave.
Yonkers,  NY  10701
Applicant Contact ARNOLD SILVERMAN
Correspondent
Skil-Care Corp.
29 Wells Ave.
Yonkers,  NY  10701
Correspondent Contact ARNOLD SILVERMAN
Regulation Number880.6760
Classification Product Code
FMQ  
Date Received03/05/2001
Decision Date 05/18/2001
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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