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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 K962963
Device Name CHECKMATE ANKLE RESTRAINT SYSTEM
Applicant
HOLLISTER, INC.
2000 HOLLISTER DR.
LIBERTYVILLE,  IL  60048
Applicant Contact JOSEPH S TOKARZ
Correspondent
HOLLISTER, INC.
2000 HOLLISTER DR.
LIBERTYVILLE,  IL  60048
Correspondent Contact JOSEPH S TOKARZ
Regulation Number880.6760
Classification Product Code
FMQ  
Date Received07/30/1996
Decision Date 10/24/1996
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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