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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 K854227
Device Name FASCILULATED NAIL
Applicant
The Deca Co.
P.O. Box 1997
Costa Mesa,  CA  92626
Applicant Contact WILLIAM HALLORAN
Correspondent
The Deca Co.
P.O. Box 1997
Costa Mesa,  CA  92626
Correspondent Contact WILLIAM HALLORAN
Regulation Number888.3020
Classification Product Code
HSB  
Date Received10/18/1985
Decision Date 02/04/1986
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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