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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 K941434
Device Name K-WIRES AND STEINMANN PINS
Applicant
Omega Surgical Instruments, Inc.
G-8305 S. Saginaw St.
Grand Blanc,  MI  48439
Applicant Contact GARY L ADAM
Correspondent
Omega Surgical Instruments, Inc.
G-8305 S. Saginaw St.
Grand Blanc,  MI  48439
Correspondent Contact GARY L ADAM
Regulation Number888.3040
Classification Product Code
HTY  
Subsequent Product Code
JDW  
Date Received03/24/1994
Decision Date 10/03/1994
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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