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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, spinal intervertebral body
510(k) Number K040655
Device Name SWIFT ANTERIOR CERVICAL PLATE SYSTEM
Applicant
DEPUY SPINE,INC
325 PARAMONT DRIVE
RAYNHAM,  MA  02767
Applicant Contact SHARON STAROWICZ
Correspondent
DEPUY SPINE,INC
325 PARAMONT DRIVE
RAYNHAM,  MA  02767
Correspondent Contact SHARON STAROWICZ
Regulation Number888.3060
Classification Product Code
KWQ  
Date Received03/12/2004
Decision Date 06/02/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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