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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 K943857
Device Name EXTERNAL FIXATOR
Applicant
Acu Med, Inc.
10950 SW 5th St.
Suite 170
Beaverton,  OR  97005
Applicant Contact SHARI L JEFFERS
Correspondent
Acu Med, Inc.
10950 SW 5th St.
Suite 170
Beaverton,  OR  97005
Correspondent Contact SHARI L JEFFERS
Regulation Number888.3040
Classification Product Code
JEC  
Date Received08/08/1994
Decision Date 01/27/1995
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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