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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 K960651
Device Name CERCLAGE WIRE CRIMP BLOCK
Applicant
Acu-Med, Inc.
10950 SW 5th, Suite 170
Beaveton,  OR  97005
Applicant Contact SHARI L JEFFERS
Correspondent
Acu-Med, Inc.
10950 SW 5th, Suite 170
Beaveton,  OR  97005
Correspondent Contact SHARI L JEFFERS
Regulation Number888.3010
Classification Product Code
JDQ  
Date Received02/15/1996
Decision Date 05/03/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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