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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Splint, Extremity, Noninflatable, External, Sterile
510(k) Number K895092
Device Name KUT-SHIELD
Applicant
KUT-GUARD, INC.
P.O. BOX 6402
HOLLYWOOD,  FL  33081
Applicant Contact WIN HIRSCH
Correspondent
KUT-GUARD, INC.
P.O. BOX 6402
HOLLYWOOD,  FL  33081
Correspondent Contact WIN HIRSCH
Regulation Number878.3910
Classification Product Code
FYH  
Date Received08/14/1989
Decision Date 09/26/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
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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