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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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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