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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cerclage, Fixation
510(k) Number K921480
Device Name OSTEO-CLAGE(TM) CERCIAGE CABLE SYSTEM
Applicant
ACU-MED, INC.
10950 SW 5TH, SUITE 170
BEAVETON,  OR  97005
Applicant Contact RANDY HUEBNER
Correspondent
ACU-MED, INC.
10950 SW 5TH, SUITE 170
BEAVETON,  OR  97005
Correspondent Contact RANDY HUEBNER
Regulation Number888.3010
Classification Product Code
JDQ  
Date Received03/30/1992
Decision Date 06/26/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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