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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Screw, Fixation, Bone
510(k) Number K111608
Device Name SLIC SCREW REPAIR SYSTEM
Applicant
Acumed, LLC
1331 H St. NW
12th Floor
Washington,  DC  20005
Applicant Contact HOLLACE RHODES
Correspondent
Acumed, LLC
1331 H St. NW
12th Floor
Washington,  DC  20005
Correspondent Contact HOLLACE RHODES
Regulation Number888.3040
Classification Product Code
HWC  
Date Received06/09/2011
Decision Date 08/29/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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