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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
510(k) Number K033856
Device Name 5.0 CANNULATED DRILL PIN, 6.0 CANNULATED DRILL-PIN
Applicant
PETER STEVENS, MD
PO BOX 58246
SALT LAKE CITY,  UT  84158
Applicant Contact PETER STEVENS, MD
Correspondent
PETER STEVENS, MD
PO BOX 58246
SALT LAKE CITY,  UT  84158
Correspondent Contact PETER STEVENS, MD
Regulation Number888.3030
Classification Product Code
KTT  
Subsequent Product Code
HWC  
Date Received12/11/2003
Decision Date 01/07/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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