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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 K071477
Device Name REVERTO 55 AND 37 SHAPE MEMORY STAPLES
Applicant
Core Essence Orthopaedics, LLC
301 Oxford Valley Rd.
Suite 905b
Yardley,  PA  19067
Applicant Contact SHAWN T HUXEL
Correspondent
Core Essence Orthopaedics, LLC
301 Oxford Valley Rd.
Suite 905b
Yardley,  PA  19067
Correspondent Contact SHAWN T HUXEL
Regulation Number888.3030
Classification Product Code
JDR  
Date Received05/29/2007
Decision Date 08/15/2007
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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