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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Rod, Fixation, Intramedullary And Accessories
510(k) Number K091788
Device Name PANTA NAIL (DIA. 10MM), PANTA NAIL XL
Applicant
Newdeal Sas
311 Enterprise Dr.
Planisboro,  NJ  08536
Applicant Contact JUDITH O'GRADY
Correspondent
Newdeal Sas
311 Enterprise Dr.
Planisboro,  NJ  08536
Correspondent Contact JUDITH O'GRADY
Regulation Number888.3020
Classification Product Code
HSB  
Date Received06/17/2009
Decision Date 07/29/2009
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
Recalls CDRH Recalls
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