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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 K070761
Device Name SANATMETAL NAILS AND PINS
Applicant
Sanatmetal Mfr. of Orthopaedic/Traumatologic Prod.
111 Hill Rd.
Douglassville,  PA  19518
Applicant Contact DONALD GUTHNER
Correspondent
Sanatmetal Mfr. of Orthopaedic/Traumatologic Prod.
111 Hill Rd.
Douglassville,  PA  19518
Correspondent Contact DONALD GUTHNER
Regulation Number888.3020
Classification Product Code
HSB  
Date Received03/20/2007
Decision Date 02/07/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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