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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 K952330
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 Received05/18/1995
Decision Date 10/05/1995
Decision Substantially Equivalent (SESE)
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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