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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Staple, Fixation, Bone
510(k) Number K962705
Device Name MLI MODULAR STAPLE
Applicant
Medicinelodge, Inc.
819 Striker Ave., Suite 10
Sacramento,  CA  95834
Applicant Contact BRIAN T CLEARY
Correspondent
Medicinelodge, Inc.
819 Striker Ave., Suite 10
Sacramento,  CA  95834
Correspondent Contact BRIAN T CLEARY
Regulation Number888.3030
Classification Product Code
JDR  
Date Received07/12/1996
Decision Date 10/01/1996
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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