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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 K884610
Device Name INTERLOCKING INTRAMEDULLARY NAILS
Applicant
Depuy, Inc.
P.O. Box 988
Warsaw,  IN  46581
Applicant Contact BARRY R SISSON
Correspondent
Depuy, Inc.
P.O. Box 988
Warsaw,  IN  46581
Correspondent Contact BARRY R SISSON
Regulation Number888.3020
Classification Product Code
HSB  
Date Received11/04/1988
Decision Date 12/01/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized
No
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