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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pin, Fixation, Smooth
510(k) Number K994232
Device Name PHALANGEAL FIXATION SYSTEM
Applicant
MEDCANICA, INC.
19526 EAST LAKE DR.
MIAMI,  FL  33015
Applicant Contact AL WEISENBORN
Correspondent
MEDCANICA, INC.
19526 EAST LAKE DR.
MIAMI,  FL  33015
Correspondent Contact AL WEISENBORN
Regulation Number888.3040
Classification Product Code
HTY  
Date Received12/16/1999
Decision Date 03/01/2000
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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