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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pin, Fixation, Smooth
510(k) Number K060654
Device Name DSI PINS AND WIRES
Applicant
Delta Surgical Instruments, Inc.
95 Schunnemunk Rd.
Highland Mills,  NY  10930
Applicant Contact DANDENIA ZABAT
Correspondent
Delta Surgical Instruments, Inc.
95 Schunnemunk Rd.
Highland Mills,  NY  10930
Correspondent Contact DANDENIA ZABAT
Regulation Number888.3040
Classification Product Code
HTY  
Subsequent Product Code
JDW  
Date Received03/13/2006
Decision Date 04/28/2006
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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