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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 K870040
Device Name INTRAMEDULLARY NAIL
Applicant
The Deca Co.
P.O. Box 1997
Costa Mesa,  CA  92626
Applicant Contact WILLIAM X HALLORAN
Correspondent
The Deca Co.
P.O. Box 1997
Costa Mesa,  CA  92626
Correspondent Contact WILLIAM X HALLORAN
Regulation Number888.3020
Classification Product Code
HSB  
Date Received01/05/1987
Decision Date 03/26/1987
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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