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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Plate, Fixation, Bone
510(k) Number K081588
Device Name RE-ZORB PLATING SYSTEM
Applicant
Acute Innovations, LLC
21421 NW Jacobson Rd.
Suite 700
Hillsboro,  OR  97124
Applicant Contact ALYSSA THOMAS
Correspondent
Acute Innovations, LLC
21421 NW Jacobson Rd.
Suite 700
Hillsboro,  OR  97124
Correspondent Contact ALYSSA THOMAS
Regulation Number888.3030
Classification Product Code
HRS  
Date Received06/05/2008
Decision Date 09/03/2008
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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