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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Screw, Fixation, Bone
510(k) Number K031050
Device Name PCW PERCUTANEOUS COMPRESSION WIRE
Applicant
Millennium Medical Technologies, Inc.
200 Gregory Ln. Suite C-100
Pleasant Hill,  CA  94523 -3389
Applicant Contact DAVID W SCHLERF
Correspondent
Millennium Medical Technologies, Inc.
200 Gregory Ln. Suite C-100
Pleasant Hill,  CA  94523 -3389
Correspondent Contact DAVID W SCHLERF
Regulation Number888.3040
Classification Product Code
HWC  
Date Received04/02/2003
Decision Date 07/14/2003
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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