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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 K061098
Device Name EBI OPTILOCK PERIARTICULAR PLATING SYSTEM
Applicant
Ebi, L.P.
399 Jefferson Rd.
Parsippany,  NJ  07054
Applicant Contact JENNIFER P HARAKAL
Correspondent
Ebi, L.P.
399 Jefferson Rd.
Parsippany,  NJ  07054
Correspondent Contact JENNIFER P HARAKAL
Regulation Number888.3030
Classification Product Code
HRS  
Subsequent Product Code
HWC  
Date Received04/19/2006
Decision Date 05/24/2006
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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