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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name component, traction, invasive
510(k) Number K965029
Device Name STABLELOC II EXTERNAL FIXATOR
Applicant
ACUMED, INC.
10950 S.W. 5TH ST.
SUITE 170
BEAVERTON,  OR  97005
Applicant Contact SHARI L JEFFERS
Correspondent
ACUMED, INC.
10950 S.W. 5TH ST.
SUITE 170
BEAVERTON,  OR  97005
Correspondent Contact SHARI L JEFFERS
Regulation Number888.3040
Classification Product Code
JEC  
Date Received12/17/1996
Decision Date 02/19/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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