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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, intraosseous
510(K) Number K964261
Device Name SMF STAINLESS STEEL BONE SCREWS
Applicant
SYNTHES (USA)
1690 russell rd.
p.o. box 1766
paoli,  PA  19301
Contact angela j silvestri
Regulation Number872.4880
Classification Product Code
DZL  
Date Received10/25/1996
Decision Date 04/11/1997
Decision substantially equivalent (SE)
Classification Advisory Committee Dental
Review Advisory Committee Dental
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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