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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Screw, Fixation, Bone
510(k) Number K910193
Device Name HUENE FIXATION SCREW
Applicant
Acu-Med, Inc.
10950 SW 5th, Suite 170
Beaveton,  OR  97005
Applicant Contact RANDALL HUEBNER
Correspondent
Acu-Med, Inc.
10950 SW 5th, Suite 170
Beaveton,  OR  97005
Correspondent Contact RANDALL HUEBNER
Regulation Number888.3040
Classification Product Code
HWC  
Date Received01/16/1991
Decision Date 08/23/1991
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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