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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name orthosis, spine, plate, laminoplasty, metal
510(k) Number K032534
Device Name SYNTHES AFS
Applicant
SYNTHES SPINE
1230 WILSON DRIVE
WEST CHESTER,  PA  19380
Applicant Contact JOHN WALSH
Correspondent
SYNTHES SPINE
1230 WILSON DRIVE
WEST CHESTER,  PA  19380
Correspondent Contact JOHN WALSH
Regulation Number888.3050
Classification Product Code
NQW  
Date Received08/15/2003
Decision Date 04/01/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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