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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 K002775
Device Name DISTAL VOLAR RADIUS FRACTURE REPAIR SYSTEM
Applicant
HAND INNOVATIONS, INC.
19526 EAST LAKE DR.
MIAMI,  FL  33015
Applicant Contact AL WEISENBORN
Correspondent
HAND INNOVATIONS, INC.
19526 EAST LAKE DR.
MIAMI,  FL  33015
Correspondent Contact AL WEISENBORN
Regulation Number888.3030
Classification Product Code
HRS  
Date Received09/06/2000
Decision Date 12/05/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
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