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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Plate, Fixation, Bone
510(k) Number K030198
Device Name HAND INNOVATIONS, INC. DISTAL RADIUS FRACTURE REPAIR SYSTEM
Applicant
Hand Innovations, Inc.
510 Stonemont Dr.
Weston,  FL  33326
Applicant Contact RICHARD D BLISS, JR.
Correspondent
Hand Innovations, Inc.
510 Stonemont Dr.
Weston,  FL  33326
Correspondent Contact RICHARD D BLISS, JR.
Regulation Number888.3030
Classification Product Code
HRS  
Date Received01/21/2003
Decision Date 04/01/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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