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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 K772081
Device Name NAIL, INTRAMEDULLARY, FLEXIBLE
Applicant
DEPUY, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
DEPUY, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number888.3020
Classification Product Code
HSB  
Date Received11/03/1977
Decision Date 11/11/1977
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
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