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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 K952739
Device Name ORTHONAIL
Applicant
Orthologic Corp.
2850 S. 36th St.
Phoenix,  AZ  85034
Applicant Contact JAMES B KOENEMAN
Correspondent
Orthologic Corp.
2850 S. 36th St.
Phoenix,  AZ  85034
Correspondent Contact JAMES B KOENEMAN
Regulation Number888.3020
Classification Product Code
HSB  
Date Received06/15/1995
Decision Date 09/15/1995
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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