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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 K931246
Device Name CERCLAGE WIRE CRIMP SLEEVE
Applicant
Acu Med, Inc.
10950 SW 5th St.
Suite 170
Beaverton,  OR  97005
Correspondent
Acu Med, Inc.
10950 SW 5th St.
Suite 170
Beaverton,  OR  97005
Regulation Number888.3010
Classification Product Code
JDQ  
Date Received03/11/1993
Decision Date 02/22/1994
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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